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