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PMA Final Decisions Rendered for November 1995 |
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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.
P940008 RES-Q ACD INTERMEDICS, INC. INDICATED FOR USE
11/28/95 ARRHYTHMIA IN PATIENTS WHO ARE
CONTROL DEVICE ANGLETON, TX AT HIGH RISK OF
EPICARDIAL 77515 SUDDEN DEATH DUE TO
PATCH AND NON- VENTRICULAR
THORACOTOMY ARRHYTHMIAS AND HAVE
LEAD (NTL) CERTAIN OTHER
SYSTEMS CONDITIONS
P940018 BARD BTA TEST BARD DIAGNOSTIC INTENDED FOR USE
11/29/95 KIT SCIENCES, INC. IN THE QUALITATIVE
REDMOND, WA MEASUREMENT OF
98052 OF BLADDER TUMOR
ASSOCIATED ANALYTES
IN HUMAN URINE TO
AID IN THE MANAGEMENT
OF BLADDER CANCER
PATIENTS
P940029 PAPNET NEUROMEDICAL THE DEVICE IS A SEMI-
11/08/95 TESTING SYSTEM SYSTEMS, INC. AUTOMATED TEST SUFFERN, NY INDICATED TO AID IN
10901 THE RESCREENING OF
CERVICAL
PAPANICOLAOU (PAP)
SMEARS PREVIOUSLY
REPORTED AS NEGATIVE
N17004/S005 SURGICAL HOWMEDICA, INC STERILIZATION
11/21/95 SIMPLEX P PROCESS CHANGE
RADIOPAQUE BONE RUTHERFORD, NJ
CEMENT 07070-2584
N17755/S046 OSTEOBOND ZIMMER, INC. ADDITION OF
11/20/95 COPOLYMER BONE WARNING STATEMENT
CEMENT WARSAW, IN TO LABELING
46581-0708
N18331/S025 PDS II ETHICON, INC. APPROVAL FOR USE OF
11/02/95 (POLYDIOXANOE) THE PDS II SUTURE IN
SUTURE, DYED & SOMERVILLE, NJ THE PANALOK
UNDYED 08876 ABSORBABLE SUTURE
ANCHOR SYSTEM
N18466/S019 CMW 1 WRIGHT MEDICAL APPROVAL FOR CMW 1
11/20/95 RADIOPAQUE, TECHNOLOGY, INC. RADIOPAQUE, CMW2 AND
CMW2 AND CMW3 ARLINGTON, TN CMW3 TO BE MARKETED
BONE CEMENTS 38002 UNDER WRIGHT MEDICAL
AS:ORTHOSET 1,
ORTHOSET 2, AND
ORTHOSET 3 BONE
CEMENT
N18466/S020 CMW1 RADIOPAQUE WRIGHT MEDICAL ADDITION OF
11/20/95 CMW2 AND CMW3 TECHNOLOGY, INC. DISTRIBUTOR LABEL
BONE CEMENTS ARLINGTON, TN AND STERILE POWDER
38002 PACKAGE PLACED INTO
A NONSTERILE
PROTECTIVE
LAMINATED FOIL
POUCH
N50510/S063 VITEK BIOMERIEUX APPROVAL FOR THE
11/16/95 LOMEFLOXACIN VITEK, INC. ADDITION OF THE
HAZELWOOD, MO ANTIMICROBIAL
63042-2395 LOMOFLOXACIN TO THE
VITEK GRAM NEGATIVE
ANTIMICROBIAL PANELS
N50510/S064 VITEK BIOMERIEUX APPROVAL FOR THE
11/27/95 PIPERACILLIN/ VITEK, INC. ADDITION OF THE
TAZOBACTAM HAZELWOOD, MO ANTIMICROBIAL
63042-2395 PIPERACILLIN/TAZOBACT
AM TO THE VITEK GRAM
NEGATIVE
ANTIMICROBIAL PANELS
P800022/S049 ZYPLAST COLLAGEN COLLAGEN CORPORATION APPROVAL FOR THE USE
11/30/95 IMPLANT OF A RANGE OF FILL
ZYDERM I AND II PALO ALTO, CA VOLUMES FOR THE ABOVE
COLLAGEN IMPLANT 94303 REFERENCED PRODUCTS
FROM 0.1ML (TEST
DOSE) TO 3ML
P810002/S036 ST. JUDE ST. JUDE APPROVAL FOR A
11/28/95 MEDICAL MEDICAL, INC. ROTATABLE VERSION OF
MECHANICAL HEART ST. PAUL, MN THE DEVICE - THE
VALVE 55117 DEVICE AS MODIFIED
WILL BE MARKETED
UNDER:ST. JUDE
MEDICAL MASTER
SERIES
P810046/S156 ACS SIMPSON- ADVANCED APPROVAL FOR AN
11/07/95 ROBERT CARDIOVASCULAR ALTERNATIVE PACKAGING
CORONARY SANTA CLARA, CA CONFIGURATION FOR THE
BALLOON 95052-8167 FINAL PRODUCT
DILATATION PACKAGING FOR ACS
CATHETER CORONARY DILATATION
CATHETERS
P830045/S050 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, INCORPORATION OF A
SENSOLOG CARDIAC SYLMAR, CA "NITROGEN BLANKET" TO
PACING SYSTEM, 91392-9221 THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P830055/S040 NEW JERSEY LCS DEPUY INC. APPROVAL FOR ADDITION
11/01/95 TOTAL KNEE SYSTEM OF A CONTRACT
WARSAW, IN STERILIZATION VENDOR,
46581-0988 SWANN-MORTON LIMITED,
OWLERTON GREEN,
SHEFFIELD, ENGLAND
P830055/S041 NEW JERSEY LCS DEPUY INC. APPROVAL OF ETHYLENE
11/06/95 TOTAL KNEE SYSTEM OXIDE STERILIZATION
WARSAW, IN FOR POLYETHYLENE
46581-0988 COMPONENTS AS AN
ALTERNATIVE TO GAMMA
RADIATION
STERILIZATION
P830060/S038 VENTAK GUIDANT, CORP. APPROVAL FOR AN
11/20/95 AUTOMATIC ALTERNATE
IMPLANTABLE ST. PAUL, MN MANUFACTURING SITE
CARDIOVERTER 55112 FOR ASSEMBLY OF THE
DEFIBRILLATOR EXTERNAL PRODUCTS
(AICD) SYSTEM
P840068/S025 DELTA GUIDANT, CORP. APPROVAL FOR
11/20/95 PACEMAKER SYSTEM ALTERNATE
ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF THE
EXTERNAL PRODUCTS
P850021/S029 AMERICAN BAXTER HEALTHCARE NEW MODEL
11/27/95 EDWARDS CORP. PURSUIT 14 PTCA
LABORATORIES SANTA ANA, CA CATHETER
HYBRID 92711-1150
PTCA
CATHETER,
PURSUIT 14
PTCA CATHETER
P850048/S011 TANDEM-R PSA HYBRITECH, INC. APPROVAL FOR
11/06/95 IMMUNORADIO- INCLUSION OF
METRIC ASSAY SAN DIEGO, CA INFORMATION AND DATA
IMMUNOMETRIC 92126 ON PSA FORMS IN THE
TANDEM-E PSA TANDEM PSA LABELING
IMMUNORADIO-
METRIC ASSAY
P860019/S102 SCIMED SCIMED LIFE NEW MANUFACTURING
11/20/95 PERCUTANEOUS SYSTEMS, INC. FACILITY AND
TRANSLUMINAL MAPLE GROVE, MN MANUFACTURE OF THE
CORONARY 55311-1566 TRAPPER PTCA
ANGIOPLASTY CATHETER IN A NON-
CATHETERS CLEANROOM ENVIORNMENT
AND TRAPPER
EXCHANGE DEVICE
P860040/S013 BIOCURVE SOFT CAL BIONICS RELOCATION OF
11/27/95 EW (METHAFILCON ALTERNATE
A) HYDROPHILIC NOVATO, CA MANUFACTURER AND
CONTACT LENSES 94947 A CHANGE IN THE
STERILIZATION
PROCESS
P880006/S023 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, INCORPORATION OF A
SENSOLOG CARDIAC SYLMAR, CA "NITROGEN BLANKET" TO
PACING SYSTEM, 91392-9221 THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P880027/S036 SCHNEIDER SCHNEIDER (USA) INC. DESIGN CHANGES, NEW
11/21/95 MICROSOFTRAC LABELING, REVISED
PTCA CATHETER MINNEAPOLIS, MN PACKAGING, NEW
SCHNEIDER 55442 MATERIAL, ADDITIONAL
FREEFLIGHT 20/ SIZES
30/40 PTCA
CATHETER
P880072/S037 MODIFIED J & C MEDICAL DEVELOPMENT APPROVAL FOR TIER A
11/01/95 LOOP MODEL PA36 RESEARCH, INC. POSTERIOR CHAMBER
POSTERIOR ST. PETERSBURG, FL INTRAOCULAR LENS
CHAMBER 33716 MODEL PA84B-OUV
INTRAOCULAR
LENS
P880086/S032 SYNCHRONY III PACESETTER, INC. APPROVAL FOR
11/01/95 AND PARAGON III ALTERNATIVE HYBRID
DUAL-CHAMBER SYLMAR, CA SUBSTRATE
PULSE GENERATORS 91392-9221
91392
P880086/S033 TRILOGY PULSE PACESETTER, INC. APPROVAL FOR
11/01/95 GENERATOR MODELS ALTERNATIVE HYBRID
235OL, 2250L, SYLMAR, CA SUBSTRATE
AND 2308L 91392-9221
P880086/S034 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, INCORPORATION OF A
SENSOLOG CARDIAC SYLMAR, CA "NITROGEN BLANKET" TO
PACING SYSTEM, 91392-9221 THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P890061/S010 VENTAK(R) P AICD GUIDANT, CORP. APPROVAL FOR
11/20/95 SYSTEM ALTERNATE
ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF THE
EXTERNAL PRODUCTS
P900023/S017 ABIOMED(R) BVS ABIOMED, INC. APPROVAL FOR THE
11/30/95 5000 ADDITION OF REFERENCE
BI-VENTRICULAR DANVERS, MA CARDS TO BE PLACED IN
SUPPORT SYSTEM 01923 A HOLDER ATTACHED TO
THE CONSOLE
P900061/S018 MEDTRONIC PCD MEDTRONIC, INC. APPROVAL FOR USE OF
11/29/95 TACHYARRHYTHMIA AN ALTERNATE
CONTROL SYSTEM MINNEAPOLIS, MN STERILIZATION PROCESS
55432-3576 AND A MODIFICATION TO
THE DISTAL END OF THE
TRANSVENE LEADS
P900061/S019 MODEL 9881E MEDTRONIC, INC. APPROVAL FOR MODEL
11/06/95 SOFTWARE 9881E SOFTWARE, 9881E
(9881E 217214 MINNEAPOLIS, MN 217214 REVISION:C,
REVISION:C) 55432-3576 FOR MODEL 9790 AND
9790C PROGRAMMERS
WITH MODEL 7216/7217
PCD AND 7201 CD
DEVICES
P910054/S001 INOUE BALLOON TORAY INDUSTRIES APPROVAL FOR A
11/30/95 CATHETER (AMERICA), INC. MODIFICATION OF THE
NEW YORK, NY STERILIZATION CYCLE
10016-4279
P910064/S011 REALITY WISCONSIN PHARMACAL APPROVAL FOR A CHANGE
11/16/95 FEMALE CONDOM CO. IN THE TYPE OF
CHICAGO, IL PACKAGING USED TO
60611 SUPPLY THE EXTRA
LUBRICANT THAT IS
SOLD WITH REALITY
P910073/S015 ENDOTAK LEAD GUIDANT, CORP. MODIFICATIONS TO
11/27/95 SYSTEM LEAD COMPONENTS
ST. PAUL, MN LEAD BODY DIAMETER, 55112-5798 NEW TRADE NAMES
P910077/S007 VENTAK PRX AICD GUIDANT, CORP. APPROVAL FOR
11/20/95 SYSTEM ALTERNATE
ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF THE
EXTERNAL PRODUCTS
P920014/S002 TCI HEARTMATE THERMO CARDIOSYSTEMS, APPROVAL FOR AN
11/17/95 IP LVAS INC. INTERIM DESIGN CHANGE
WOBURN, MA OF THE PERCUTANEOUS
01888-2697 VENT LEAD (PVL)
P920047/S001 EPT-1000 TC EP TECHNOLOGIES, ALTERNATE
11/08/95 CARDIAC ABLATION INC. CONFIGURATION OF
SYSTEM WITH SUNNYVALE, CA THE EPT-1000 CARDIAC
TEMPERATURE 94086 ABLATION CONTROLLER
CONTROL WHICH INCORPORATES
A TEMPERATURE CONTROL
FEATURE
P930030/S001 ACTIFOAM BIOETICA, INC. APPROVAL FOR A CHANGE
11/30/95 ABSORBABLE IN TRADE NAME THE
COLLAGEN PORTLAND, ME DEVICE AS MODIFIED
HEMOSTATIC SPONGE 04101 WILL BE MARKETED
UNDER THE TRADE NAME
ACTIFOAM ABSORBABLE
COLLAGEN HEMOSTATIC
SPONGE
P930035/S003 VENTAK P2 GUIDANT, CORP. APPROVAL FOR
11/20/95 AICD SYSTEM ALTERNATE
ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF
EXTERNAL PRODUCTS
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