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PMA Final Decisions Rendered for July 1996 |
P940035 MATRITECH MATRITECH, INC. APPROVAL FOR THE 07/02/96 NMP22 TEST KIT NEWTON, MA MATRITECH NMP22 TEST 02160 KIT IS INDICATED AS AN AID IN THE MANAGEMENT OF PATIENTS WITH TRANSITIONAL CELL CARCINOMA OF THE URINARY TRACT (TCC/UT) AFTER SURGICAL TREATMENT TO IDENTIFY THOSE PATIENTS WITH OCCULT OR RAPIDLY RECURRING TCC/UT
N17755/S047 OSTEOBOND ZIMMER, INC. ADDITION OF 07/31/96 COPOLYMER BONE TERMINOLOGY OF "HALF CEMENT WARSAW, IN BATCH, SINGLE BATCH, 46581-0708 DOUBLE BATCH, HALF PACK, SINGLE PACK, AND DOUBLE PACK" TO THE PACKAGE LABELS P810046/S161 ACS OTW LIFESTREAM ADVANCED APPROVAL FOR THE ACS 07/29/96 CORONARY CARDIOVASCULAR SYSTEMS OTW LIFESTREAM DILATATION SANTA CLARA, CA CORONARY DILATATION CATHETER WITH THE 95052-8167 CATHETER WITH A 30 MM 30 MM BALLOON BALLOON LENGTH LENGTH P820003/S073 MODEL 5348 MEDTRONIC, INC. MODIFICATIONS TO THE 07/16/96 TEMPORARY KEYPAD OF THE MODEL PACEMAKER MINNEAPOLIS, MN 5348 TEMPORARY 55432-3576 PACEMAKER P820018/S063 AUTIMA/AURORA TELECTRONICS CHANGE IN 07/23/96 CARDIAC PACING PACING SYSTEM STERILIZATION SYSTEM ENGLEWOOD, CO CONTRACTOR: GRIFFITH 80112 MICRO SCIENCE, INC., SMYRNA, GA 30080-7322 P820018/S065 REFLEX MODEL TELECTRONICS CHANGE IN 07/23/96 8223E PACING SYSTEM STERILIZATION ENGLEWOOD, CO CONTRACTOR: GRIFFITH 80112 MICRO SCIENCE, INC., SMYRNA, GA 30080-7322 P820018/S066 REFLEX DDD TELECTRONICS PACING APPROVAL FOR THE USE 07/11/96 MODEL 1254 META SYSTEMS, INC. OF WILSON GREATBATCH DDDR AND META II ENGLEWOOD, CO BATTERIES WHICH HAVE PULSE GENERATORS 80112 UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING P830055/S046 NEW JERSEY LCS DEPUY, INC. ADDITION OF THE 07/17/96 TOTAL KNEE DISTRIBUTION CENTER POROUS-COATED SYSTEM WARSAW, IN METAL-BACKED, 46581-0988 TEXTURED METAL-BACKED, AND ALL-POLYETHYLENE THREE-PEGGED PATELLA COMPONENT OPTIONS P840039/S048 EZE-FIT STORZ OPHTHALMICS, APPROVAL FOR THE 07/18/96 INC. TRADE NAME EZE-FIT CLEARWATER, FL FOR THE ONE-PIECE 34619 POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES P850070/S008 STERILE AUTOMATIC LIQUID ALTERNATE CLOSURE 07/10/96 PRESERVED PACKAGING, INC. DESIGN WHICH UTILIZES SALINE WOODSTOCK, IL A PIERCING CAP AND SOLUTION 60098-7498 "FLIP-TOP" ON 12 OZ. AND 16 OZ. PRESERVED SALINE SOLUTION CONTAINERS ONLY P860004/S022 MEDTRONIC MODELS MEDTRONIC, INC. 10CC SYNCHROMED 07/29/96 8616-10 AND 8616- IMPLANTABLE 10 (10CC) MODELS MINNEAPOLIS, MN PROGRAMMABLE 8616-18, 8617-18, 55440-9087 INFUSION PUMP MODELS 8617L-18, 8618- 8616-10 AND 8617-10; 18 AND 8618L AND TO CHANGE THE (18CC) INDICATIONS FOR THE PROGRAMMABLE LIORESAL INTRATHECAL INFUSION PUMPS 18CC RESERVOIR P860005/S005 PRO OSTEON INTERPORE INTL. REVISION TO THE 07/18/96 IMPLANT 500 POST-MARKET STUDY CORALLINE IRVINE, CA PROTOCOL HYDROXYAPATITE 92718-2402 BONE VOID FILLER P860019/S111 SCIMED SURPASS SCIMED LIFE APPROVAL FOR THE PERCUTANEOUS SYSTEMS, INC. SCIMED SURPASS TRANSLUMINAL 55311-1566 PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY CORONARY (PTCA) PERFUSION ANGIOPLASTY CATHETER (PTCA) PERFUSION CATHETER P860026/S005 DIAPHRAGMATIC/ AVERY LABORATORIES, CHANGE IN 07/09/96 PHRENIC NERVE INC. MANUFACTURING STIMULATOR COMMACK, NY FACILITY TO AVERY 11725-5703 LABORATORIES INC., COMMACK, NEW YORK P860027/S011 MAESTRO II CARDIAC CONTROL ALTERNATE 07/09/96 MODEL 533 SYSTEMS, INC STERILIZATION PACEMAKER SYSTEM PALM COAST, FL PROCEDURE 32164 P870023/S007 DESTAT 4 ALLERGAN ALTERNATE 07/12/96 CLEANING, OPTICAL MANUFACTURING DISINFECTING AND IRVINE, CA SITE:ALLERGAN STORAGE SOLUTION 92713-9534 OPTICAL, 8301 MARS DRIVE, WACO, TEXAS 76712 P870025/S005 COROMETRICS MODEL COROMETRICS MEDICAL APPROVAL FOR A 07/17/96 146 FETAL SYSTEMS, INC. LABELING CHANGE TO ACOUSTICS WALLINGFORD, CT PERMIT INTERFACE OF STIMULATOR 06492-0333 THE COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR WITH THE COROMETRICS MODEL 155 FETAL MONITOR P870072/S001 THORATEC THORATEC LABORATORIES APPROVAL FOR ADDING 07/10/96 VENTRICULAR CORPORATION REFERENCES TO THE ASSIST DEVICE BERKELEY, CA DIRECTIONS FOR USE (VAD) SYSTEM 94710-2090 P880003/S060 CORDIS PTCA CORDIS CORPORATION MODIFIED HUB BONDING 07/26/96 DILATATION PROCESS CATHETER MIAMI, FL TRAKSTAR 14, 33102-5700 TRAKSTAR 18 AND OLYMPIX II PTCA DILATATION CATHETERS P880027/S039 SCHNEIDER GOLDIE SCHNEIDER (USA), APPROVAL FOR THE 07/01/96 AND GOLDIE LONGY INC. GOLDIE AND GOLDIE PTCA CATHETERS MINNEAPOLIS, MN LONGY PTCA CATHETER 55442 LINES P880038/S028 MEDA-MV PACING TELECTRONICS CHANGE IN 07/23/96 SYSTEM PACING SYSTEMS STERILIZATION ENGLEWOOD, CO CONTRACTOR: GRIFFITH 80112 MICRO SCIENCE, INC. SMYRNA, GA 30080-7322 P880038/S029 META II PULSE TELECTRONICS APPROVAL FOR USE OF 07/11/96 GENERATOR PACING SYSTEMS, INC. WILSON GREATBATCH MODEL 1254 ENGLEWOOD, CO BATTERIES WHICH HAVE 80112 UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING P880091/S006 ULTRAVIOLET- STAAR SURGICAL ADDITION OF ALTERNATE 07/01/96 ABSORBING ELASTIC COMPANY VENDOR FOR PART OF AND ELASTIMIDE MONROVIA, CA THE MANUFACTURING POSTERIOR CHAMBER 91016 PROCESS INTRAOCULAR LENSES (IOLS) P890003/S043 MEDTRONIC THERA, MEDTRONIC, INC. APPROVAL FOR 07/01/96 PRODIGY AND PREVA MARKETING OF A SUBSET PULSE GENERATORS MINNEAPOLIS, MN OF PULSE GENERATORS VITATRON LEGACY II 55432-3576 FROM THE APPROVED AND VISA PULSE THERA-I/PRODIGY GENERATORS HARDWARE AND SOFTWARE PLATFORMS P890023/S003 OCUFILCON D OCULAR SCIENCES/ APPROVAL FOR TINTING, 07/12/96 SPHERICAL AND AMERICAN HYDRON WET PROCESSING, TORIC EXTENDED CUPERTINO, CA PACKAGING, AND WEAR CONTACT 95014 STERILIZATION AT THE LENSES FACILITY LOCATED AT SANTA ISABEL INDUSTRIAL PARK, PUERTO RICO 00757 P890039/S015 MAESTRO II CARDIAC CONTROL ALTERNATE 07/09/96 SAVVI PACING SYSTEMS, INC STERILIZATION SYSTEM MODEL 325 PALM COAST, FL PROCEDURE AND MODEL 333 32164 P900060/S010 CARBOMEDICS CARBOMEDICS, INC. USE OF AN AUTOMATED 07/02/96 PROSTHETIC HEART LASER SYSTEM FOR VALVE, MODELS S500 AUSTIN, TX CUTTING SEWING CUFF AND 700 78752-1793 MATERIAL P900061/S022 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR 07/01/96 7221 B/C/CX/D/E MEDTRONIC MODEL 7221 MICRO JEWEL MINNEAPOLIS, MN B/C/CX/D/E MICRO W/MODEL 5434 55432-3576 JEWEL WITH THE MODEL ACTIVE CAN 5434 ACTIVE CAN EMULATOR AND EMULATOR AND MODEL MODEL 9894 9894 SOFTWARE SOFTWARE P900070/S009 META DDDR PACING TELECTRONICS PACING CHANGE IN 07/23/96 SYSTEM SYSTEMS STERILIZATION ENGLEWOOD, CO CONTRACTOR: GRIFFITH 80112 MICRO SCIENCE, INC. SMYRNA, GA 30080-7322 P900070/S010 META DDDR PULSE TELECTRONICS PACING APPROVAL FOR THE USE 07/11/96 GENERATOR MODEL SYSTEMS, INC. OF WILSON GREATBATCH 1254 ENGLEWOOD, CO BATTERIES WHICH HAVE 80112 UNDERGONE A MODIFIED ACCELERATED BURN-IN PROCEDURE FOR ACCEPTANCE TESTING P910020/S012 UNITY MODEL 292-07 INTERMEDICS, INC. APPROVAL FOR THE 07/31/96 SINGLE PASS (VDDR) UNITY MODEL 292-07 PULSE GENERATOR ANGLETON, TX SINGLE PASS (VDDR) WITH UNIPASS LEADS 77515 PULSE GENERATOR WITH MODELS 425-02, UNIPASS LEADS MODELS 425-04 AND 425-06 425-02, 425-04 AND AND MODEL 531-60 425-06 AND MODEL 531- GRAPHICS PROGRAM 60 GRAPHICS PROGRAM MODULE MODULE P920015/S011 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR THE 07/26/96 6932 LEAD MEDTRONIC PUERTO MINNEAPOLIS, MN RICO, INC., VILLALBA 55432-3576 WEST INDUSTRIAL AREA, VILLALBA, PUERTO RICO TO MANUFACTURE THE MEDTRONIC MODEL 6932 LEAD P920032/S003 MICRO-PACE PACE MEDICAL, INC. ALTERNATE VENDOR FOR 07/19/96 MODEL 4553 THE CALIBRATED MODULE WALTHAM, MA ASSEMBLY FOR THE 02154 MICRO-PACE MODEL 4553 P930027/S001 IMMULITE PSA DIAGNOSTIC PRODUCTS APPROVAL TO CHANGE 07/11/96 CORP. THE IMMUNORADIOMETRIC LOS ANGELES, CA TEST SYSTEM FOR THE 90045 MEASUREMENT OF PSA TO A SOLID PHASE, TWO SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY
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