FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for May 1996 |
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.
P910072 SYVA MICRO BEHRING DIAGNOSTICS, USE AN AID IN THE 05/13/96 TRAK(R)II IGM INC. DIAGNOSIS OF ACUTE ANTI-HAV EIA SAN JOSE, CA OR RECENT HEPATITIS 95161 INFECTION (USUALLY SIX MONTHS OR LESS) P920023 UROLUME AMERICAN MEDICAL USE IN MEN TO RELIEVE 05/06/96 ENDOURETHRAL SYSTEMS, INC. URINARY OBSTRUCTION PROSTHESIS MINNETONKA, MN SECONDARY TO RECURRENT 55343 BENIGN BULBAR URETHRAL STRICTURES P940019 WALLSTENT SCHNEIDER (USA), INDICATED FOR USE 05/28/96 ILIAC INC. FOLLOWING SUBOPTIMAL ENDOPROSTHESIS PLYMOUTH, MN PERCUTANEOUS 55442 TRANSLUMINAL ANGIOPLASTY (PTA) OF COMMON AND/OR EXTERNAL ILIAC ARTERY STENOTIC LESIONS P950001 SELUTE STEROID GUIDANT, CORP. INDICATED FOR CHRONIC 05/08/96 ELUTING PACING AND SENSING ENDOCARDIAL LEAD ST PAUL, MN OF THE VENTRICLE MODELS 4185 AND 55112-5798 WHEN USED WITH A 4285 COMPATIBLE PULSE GENERATOR P950014 PROSTATRON EDAP TECHNOMED A NON-SURGICAL 05/03/96 GROUP (USA), INC. TREATMENT ALTERNATIVE CAMBRIDGE, MA TO TRANSURETHRAL 02139 RESECTION OF THE PROSTATE (TURP) FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) P950022 TVL LEAD SYSTEM VENTRITEX, INC. INDICATED FOR USE AS 05/10/96 A TRANSVENOUS SUNNYVALE, CA DEFIBRILLATION LEAD 94086-6527 SYSTEM IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY VENTRICULAR TACHYARRHYTHMIAS P950039 THINPREP CYTYC, CORP. REPLACEMENT FOR THE 05/20/96 2000 SYSTEM CONVENTIONAL METHOD MARLBOROUGH, MA OF PAP SMEAR 01752 PREPARATION IN SCREENING FOR ATYPICAL CELLS, CERVICAL CANCER, OR PRECURSOR LESIONS
N12159/S016 SURGICEL JOHNSON & JOHNSON APPROVAL FOR THE 05/15/96 FIBRILLAR MEDICAL, INC. 4"X4" SIZE OF ABSORBABLE ARLINGTON, TX SURGICEL FIBRILLAR HEMOSTAT 76004-3130 ABSORBABLE HEMOSTAT P790017/S058 USCI GRUNTZIG C.R. BARD, INC. APPROVAL FOR THE USCI 05/13/96 DILICA CORONARY PROCROSS ELITE OVER ARTERY AND USCI BILLERICA, MA THE WIRE BALLOON PROCROSS ELITE 01821 DILATATION CATHETER OVER THE WIRE WITH PRO/PEL COATING BALLOON AND ANTI BACK BLEED DILATATION DEVICE CATHETERS P790018/S024 MEDTRONIC HALL MEDTRONIC, INC. APPROVAL FOR THE USE 05/13/96 PROSTHETIC HEART OF OCCLUDERS MADE BY VALVE AND VALVED MINNEAPOLIS, MN MEDTRONIC CARBON CONDUITS MODELS 55440 IMPLANTS (MCI) OF A7700, M7700, AUSTIN, TEXAS, AS A C7700, AND Z7700 COMPONENT TO THE DEVICE P790019/S006 HAVAB-M ABBOTT LABORATORIES APPROVAL TO EXTEND 05/29/96 DIAGNOSTIC KIT EXPIRATION DATING TO NORTH CHICAGO, IL 70 DAYS FROM THE DATE 60064-3500 OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS P790019/S007 HAVAB-M EIA ABBOTT LABORATORIES APPROVAL TO EXTEND 05/29/96 DIAGNOSTIC KIT EXPIRATION DATING TO ABBOTT PARK, IL 8 MONTHS FROM THE 60064-3500 DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUS P790025/S006 ABBOTT HBE ABBOTT LABORATORIES MODIFIED LABELING 05/17/96 (RDNA) EIA TO ENHANCE THE SAFETY ABBOTT PARK, IL IN THE USE OF THE 60064-3500 DEVICE P790027/S059 POSTERIOR AND CHIRON VISION CORP. IMPLEMENTATION OF NEW 05/01/96 ANTERIOR CHAMBER MANUFACTURING POLYMETHYLMETHA- CLAREMONT, CA PROCESSES OF CLEAR CRYLATE 91711 AND VIOLET HAPTIC INTRAOCULAR POLYMETHLYMETHACRYLATE LENSES (PMAA) ONE-PIECE POSTERIOR CHAMBER LENSES P810002/S040 ST. JUDE MEDICAL ST. JUDE MEDICAL, INCREASE OF THE 05/01/96 MECHANICAL HEART INC. LEAFLET LOT SIZES VALVE ST. PAUL, MN DURING THE PYROLYTIC 55117 CARBON COATING PROCESS P810002/S042 ST. JUDE MEDICAL ST. JUDE MEDICAL, LABELING CHANGE 05/14/96 MECHANICAL HEART INC. VALVE ST. PAUL, MN 55117 P830026/S065 RX5000 INTERMEDICS, INC. ALTERNATE 05/30/96 PROGRAMMER COMPONENTS MODEL 522-12 ANGLETON, TX 77515 P830055/S047 NEW JERSEY LCS DEPUY, INC. COMBINATION LABELING 05/06/96 TOTAL KNEE SYSTEM TO INCLUDE THE WARSAW, IN CEMENTED AND 46581-0988 CEMENTLESS DEVICE CONFIGURATIONS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM INTO ONE SINGLE LABEL P840024/S062 NUCLEUS 22 COCHLEAR, CORP. MODIFICATIONS TO THE 05/20/96 CHANNEL COCHLEAR EXTERNAL TRANSMITTER IMPLANT SYSTEM ENGLEWOOD, CO COIL TO LIMIT ESD 80112 ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL P850048/S012 TANDEM-R PSA HYBRITECH, INC. CHANGE IN HYBRITECH'S 05/03/96 IMMUNORADIOMETRIC IMMUNOENZYMETRIC PSA ASSAY & TANDEM-E SAN DIEGO, CA ASSAY FROM A BEAD PSA 921269006 FORMAT TO A IMMUNOENZYMETRIC MICROPLATE (MP) ASSAY FORMAT (TANDEM-MP PSA ASSAY) P850059/S016 POSTERIOR AND CHIRON VISION CORP. NEW MANUFACTURING 05/01/96 ANTERIOR CHAMBER PROCESS, NEW TUMBLING POLYMETHYLMETHA- CLAREMONT, CA PROCESS, AND CRYLATE 91711 INTRODUCTION OF INTRAOCULAR SEVERAL NEW TIER A LENSES POSTERIOR CHAMBER LENSES P860003/S027 UVAR THERAKOS MANUFACTURING SITE 05/17/96 PHOTOPHORESIS CHANGE FOR THE TPS102 SYSTEM WEST CHESTER, PA PHOTOCEPTOR COMPONENT 19380 OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS P860007/S016 INTERTACH INTERMEDICS, INC. ALTERNATE 05/21/96 FAMILY OF PULSE STERILIZATION PROCESS GENERATORS ANGLETON, TX 77515 P860059/S075 UV-ABSORBING ALLERGAN MEDICAL APPROVAL FOR TIER A 05/30/96 POSTERIOR CHAMBER OPTICS POSTERIOR CHAMBER INTRAOCULAR IRVINE, CA LENSES, MODELS LENSES 92713-9534 UPB38ON, UPB38OC, UPB320F, UPB320V, UPB330F, UPB382, AND UPB300F P870013/S008 POSTERIOR AND CHIRON VISION CORP. NEW MANUFACTURING 05/01/96 ANTERIOR CHAMBER PROCESS, NEW POLYMETHYLMETHA- CLAREMONT, CA TUMBLING PROCESS, CRYLATE 91711 INTRODUCTION OF INTRAOCULAR SEVERAL TIER A LENSES POSTERIOR CHAMBER LENSES P870015/S024 MEDSTONE STS MEDSTONE INTL., REVISION TO THE 05/24/96 LITHOTRIPTER INC. "PRECAUTIONS" SECTION ALISO VIEJO, CA OF THE USER'S MANUAL 92656-4114 P870049/S025 MICROSCAN DADE INTL., INC. EXPANDED GENTAMICIN 05/03/96 RAPID FLUOROGENIC DILUTIONS AND THE PANELS-GENTAMCIN WEST SACRAMENTO, CA REMOVAL OF LIMITATION GRAM-NEGATIVE 95691 FOR TESTING OF PANELS SALMONELLA/SHIGELLA WITH GENTAMICIN AND ADDITIONAL LIMITATIONS P870072/S002 THORATEC THORATEC LABORATORIES ADD AN INCOMING 05/01/96 VENTRICULAR CORP. INSPECTION TEST ASSIST DEVICE BERKELEY, CA TO THE QUALITY (VAD) SYSTEM 94710-2090 ASSURANCE PROCEDURES FOR EPROM INTEGRATED CIRCUITS P880003/S057 CORDIA PTCA CORDIS CORPORATION APPROVAL FOR TITAN 05/06/96 DILATION AND TITAN XL PTCA CATHETER MIAMI, FL DILATATION CATHETERS 33102-5700 WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND A MODIFIED HUB BONDING P890017/S004 PALMAZ BALLOON- JOHNSON & JOHNSON ALTERNATE 05/20/96 EXPANDABLE STENT/ INTERVENTIONAL MANUFACTURING ILIAC ARTERIES WARREN, NJ FACILITY FOR 07059 FINISHING, PACKAGING, AND DISTRIBUTION OF THE DEVICE P890027/S031 NUCLEUS 22 COCHLEAR, CORP. MODIFICATIONS TO THE 05/20/96 CHANNEL COCHLEAR EXTERNAL TRANSMITTER IMPLANT ENGLEWOOD, CO COIL TO LIMIT ESD 80112 ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL P900023/S018 ABIOMED BVS 5000 ABIOMED, INC. CLARIFICATION OF THE 05/02/96 BI-VENTRICULAR LABELED INDICATION SUPPORT SYSTEM DANVERS, MA 01923 P900043/S002 PALMAZ-SCHATZ JOHNSON & JOHNSON REVISED LABELING 05/01/96 BALLOON INTERVENTIONAL SYSTEMS EXPANDABLE STENT WARREN, NJ 07059 P900056/S014 ROTABLATOR HEART TECHNOLOGY, INC. APPROVAL FOR THE 05/16/96 ROTATIONAL SUPPORT ROTAWIRE AND ANGIOPLASTY REDMOND, WA RAIL ROTAWIRE GUIDE SYSTEM 98052-3376 WIRES FOR USE WITH THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM P900061/S017 MEDTRONIC MODELS MEDTRONIC, INC. APPROVAL FOR 05/07/96 7200B/C/D/E MEDTRONIC MODELS MINNEAPOLIS, MN 7220B/C/D/E WITH 55432-3576 MODIFIED MICROPROCESSOR P910020/S013 MARATHON FAMILY INTERMEDICS, INC. APPROVAL FOR THE 05/03/96 OF PULSE MARATHON FAMILY OF GENERATORS AND ANGLETON, TX PULSE GENERATORS AND THE MODEL 531-66 77515 THE MODEL 531-66 GRAPHICS PROGRAM GRAPHICS PROGRAM MODULE MODULE P910023/S013 CADENCE TIERED VENTRITEX, INC. ALTERNATIVE 05/13/96 THERAPY STERILIZATION PROCESS DEFIBRILLATOR SUNNYVALE, CA AND USE OF EASY-TO- SYSTEM 94086-6527 RETRIEVE BIOLOGICAL INDICATORS P910023/S019 CADET TIERED VENTRITEX, INC. APPROVAL FOR THE 05/07/96 THERAPY CADET TIERED THERAPY DEFIBRILLATOR SUNNYVALE, CA DEFIBRILLATOR SYSTEM SYSTEM 94086-6527 (PECTORAL USE) P910031/S007 CATHSCANNER ORACLE ENDOSONICS CORP. ADDITIONAL 05/30/96 MICRO PTCA MANUFACTURING SITE: CATHETER, FACT, RANCHO CORDOVA, CA IRVINE, CA. AND AND ARC BALLOON 95670 ALTERNATE CORONARY STERILIZATION SITE: DILATATION CATHETER LOS ANGELES, CA. P910073/S020 ENDOTAK C LEAD GUIDANT, CORP. ADDITION OF A SUB 05/15/96 MODELS, SQ PATCH POPULATION TO THE MODELS, SQ LEAD ST.PAUL, MN INDICATIONS FOR USE ARRAY MODELS, 55112-5798 FOR ENDOTAK C, SQ AND AND DSP LEAD DSP LEADS MODELS P910077/S015 VENTAK PRX AICD GUIDANT CORP. ADDITION OF A SUB 05/15/96 MODELS, PRX II POPULATION TO THE AICD MODELS, PRX ST. PAUL, MN INDICATIONS FOR USE III AICD MODELS, 55112 FOR VENTAK PRX, MINI AICD MODELS, PRX II, PRX III, MINI HC AICD MINI AICD, MINI HC MODELS, AND MINI AICD, AND MINI II II AICD MODELS AICD LEADS P930012/S003 PROGRESSIVE PROGRESSIVE APPROVAL FOR THE PAS 05/22/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS CHAMPION PTCA SYSTEMS CHAMPION MENLO PARK, CA CATHETERS PTCA CORONARY 94025 DILATATION CATHETER P930035/S005 VENTAK P2 AICD GUIDANT, CORP. ADD PATIENT GROUP 05/15/96 MODEL 1625 AND TO THE INDICATIONS VENTAK P3 AICD ST PAUL, MN FOR USE MODELS 1630 AND 55112-5798 1635 P940007/S001 MODEL 127, PHARMACIA, INC. APPROVAL FOR TIER B 05/20/96 PLIOLENS POSTERIOR CHAMBER ULTRAVIOLET- DUBLIN, OH INTRAOCULAR LENS ABSORBING SILICONE 43216 MODEL 127 AS A POSTERIOR CHAMBER PATIENT LENS INTRAOCULAR LENS
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH