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Medical Devices
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July 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 1996. This list is generated on a monthly basis.
PMA Original Approvals
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
PMA Original Approvals
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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