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PMA Final Decisions Rendered for August 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.
P930030 HEMOSTAGENE BIOETICA, INC. FOR USE IN
08/15/95 ABSORBABLE SURGICAL PROCEDURES
COLLAGEN PORTLAND, ME (OTHER THAN
HEMOSTATIC 04101 NEUROSURGICAL
SPONGE OPHTHALMIC AND
UROLOGICAL) AS AN
ADJUNCT TO HEMOSTASIS
IN ADULT WOMEN
N17755/S044 ZIMMER ZIMMER, INC. CHANGES IN BONE
08/11/95 OSTEOBOND WARSAW, IN CEMENT COMPOSITION
COPOLYMER 46581-0708
BONE CEMENT
P800036/S030 INFUSAID INFUSAID, INC. LABELING CHANGE
08/14/95 IMPLANTABLE REGARDING
INFUSION NORWOOD, MA CHLOROFLUOROCARBON
PUMP 02062 (CFC) AND CFC IN
PUMP IS "ESSENTIAL
USE"
P810002/S037 ST. JUDE ST. JUDE MEDICAL, USE OF PROOF TESTING
08/11/95 MEDICAL INC. IN THE EVALUATION OF
MECHANICAL ST. PAUL, MN ST. JUDE MEDICAL
HEART VALVE 55117 MECHANICAL HEART
VALVES CONSTRUCTED
WITH CARBOMEDICS, INC.
MANUFACTURED COMPONENTS
P830060/S039 MODEL 0010 GUIDANT, CORP. DESIGN CHANGES TO THE
08/28/95 BIPOLAR MODEL 0010 LEAD AND TO
ENDOCARDIAL ST. PAUL, MN USE A "TRAY-IN-TRAY"
LEAD 55112-5798 PACKAGING SYSTEM FOR
THE LEAD
P840001/S037 MEDTRONIC MEDTRONIC APPROVAL OF
08/29/95 ITREL 3 SPINAL NEUROLOGICAL MEDTRONIC ITREL 3
CORD STIMULATION MINNEAPOLIS, MN SPINAL CORD STIMULATION
(SCS) SYSTEM 55440-9087 (SCS) SYSTEM FOR THE
TREATMENT OF CHRONIC
INTRACTABLE PAIN OF THE
TRUNK AND/OR LIMBS
P840008/S050 DORNIER DORNIER MEDICAL APPROVAL FOR A NEW
08/21/95 LITHOTRIPTER SYSTEMS, INC. MODEL LITHOTRIPTER
KENNESAW, GA INDICATED FOR
30144 FRAGMENTATION OF 5 TO
25 MILLIMETER KIDNEY
STONES SUCH AS RENAL
CALYX AND RENAL PELVIC
P840024/S046 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR USE IN
08/21/95 CHANNEL COCHLEAR AN ADULT EXPANDED
IMPLANT ENGLEWOOD, CO POPULATION
LENSES 80112
P840024/S056 NUCLEUS 22 COCHLEAR, CORP. INTRODUCTION OF A
08/31/95 CHANNEL COCHLEAR DPI TRIGGER OUT CABLE
IMPLANT FOR USE ENGLEWOOD, CO
IN ADULTS 80112
P840024/S057 NUCLEUS 22 COCHLEAR, CORP. MODIFICATION TO THE
08/24/95 CHANNEL COCHLEAR NEGATIVE BATTERY
IMPLANT FOR USE ENGLEWOOD, CO TERMINAL ON THE
IN ADULTS 80112 SPECTRA-22 AND MINI
SPEECH PROCESSORS
P840040/S048 SEQUEL BOSTON SCIENTIFIC, NEW PTCA CATHETER
08/29/95 CONVERTIBLE CORP. CREATED BY THE
RAPID EXCHANGE NATICK, MA MODIFICATION OF
PTCA CATHETER 01760-1537 SYNERGY II PTCA
CATHETER; TRADE NAME
IS SEQUEL CONVERTIBLE
RAPID EXCHANGE PTCA
CATHETER
P840064/S014 DUOVISC ALCON LABORATORIES, MODIFICATION TO THE
08/02/95 VISCOELASTIC INC. DUOVISC PACKAGE INSERT
SYSTEM PACKAGE FORT WORTH, TX TO ALLOW FOR USE OF
INSERT 76134-2099 BOTH DEVICES IN A
SINGLE OPHTHALMIC
PROCEDURE
P860019/S100 SCIMED LEAP SCIMED LIFE NEW PTCA CATHETER
08/17/95 EXPRESS PLUS SYSTEMS, INC. BASED ON MODIFICATIONS
PTCA CATHETER MAPLE GROVE, MN TO THE SCIMED EXPRESS
55311-1566 PLUS II PTCA CATHETER;
TRADE NAME:SCIMED LEAP
EXPRESS PLUS PTCA
CATHETER
P860019/S101 SCIMED EXPRESS SCIMED LIFE CHANGE THE SCIMED
08/22/95 PLUS II SYSTEMS, INC. EXPRESS PLUS II PTCA
PERCUTANEOUS MAPLE GROVE, MN CATHETER'S NAME TO
TRANSLUMINAL 55311-1566 POC EXPRESS PLUS AND
CORONARY MODIFY LABELING
ANGIOPLASTY
(PTCA) CATHETER
P860019/S103 SCIMED PTCA SCIMED LIFE ADDITION OF QUARTER
08/15/95 CATHETERS/SCIMED SYSTEMS, INC. SIZE BALLOONS TO THE
BANDIT PTCA MAPLE GROVE, MN SCIMED BANDIT, LONG
CATHETERS 55311-1566 BANDIT 30, AND THE
SCIMED LONG BANDIT
40 PTCA CATHETER
LINES
P870045/S036 MODEL SP38UB CHIRON VISION, APPROVAL FOR
08/11/95 POSTERIOR CHAMBER CORP. MODEL SP38UB
INTRAOCULAR IRVINE, CA
LENS 92718-1903
P880003/S026 CORDIS PTCA CORDIS, CORP. ALTERNATE
08/04/95 DILATATION STERILIZATION SITE
CATHETERS AND MIAMI, FL AND ELIMINATION OF
ORION STEERABLE 33102-5700 CHLOROFLUOROCARBONS
PTCA BALLOON FROM STERILIZATION
CATHETER PROCESS
P880003/S048 CORDIS PTCA CORDIS, CORP. APPROVAL FOR TITAN
08/14/95 DILATATION XL PTCA DILATATION
CATHETER/TITAN MIAMI, FL CATHETERS WITH A
XL PTCA 33102-5700 USABLE LENGTH OF
DILATATION 155 CM
CATHETERS
P880038/S030 META II MODEL TELECTRONICS, INC. TELEMETRY COIL
08/14/95 1204H PULSE IMPROVEMENT, SCAMP
GENERATOR/META WASHINGTON, D.C. PROCESSOR MICROCODE
III MODELS 1206, 20036 MODIFICATION, AND
1206E, 1206M SUBSTITUTION OF DOW
PULSE GENERATORS SILASTIC MEDICAL
ADHESIVE TYPE A
P880072/S030 MDLS GL55A-OUV, MDR, INC. RESPONSE TO FDA'S
08/24/95 GL55B-OUV, 28-APR-95 LETTER
PS40D-OUV, ST. PETERSBURG, FL REGARDING MDR'S
PS60C-OUV, 33716 1992 AND 1993
PB61B-OUV, ANNUAL REPORTS AND
PB07C-OUV, AND REQUESTED TIER A
LP57L-OUV APPROVALS
P880072/S034 MODEL PL52B-OUV MDR, INC. TIER A APPROVAL
08/24/95 ULTRAVIOLET- MODEL PL52B-OUV
ABSORBING ST. PETERSBURG, FL
POSTERIOR 33716
CHAMBER
INTRAOCULAR
LENS (IOL)
P880072/S035 MODIFIED J & C MDR, INC. TIER A APPROVAL
08/07/95 LOOP MODEL PA36 MODEL P55OC-OUV
POSTERIOR ST. PETERSBURG, FL
CHAMBER 33716
INTRAOCULAR
LENS
P890003/S040 MEDTRONIC MEDTRONIC, INC. MODEL 9877A
08/15/95 MODEL 9877A SOFTWARE DISKETTE
SOFTWARE MINNEAPOLIS, MN WHICH PROVIDES
DISKETTE 55432-3576 ELECTROPHYSIOLOGY
STUDY (EPS)
SOFTWARE WITH
BACKUP VENTRICULAR
PACING
P890027/S026 NUCLEUS 22 COCHLEAR, CORP. APPROVAL FOR
08/31/95 CHANNEL COCHLEAR INTRODUCTION OF A
IMPLANT FOR USE ENGLEWOOD, CO DPI TRIGGER OUT
IN CHILDREN 80112 CABLE
P890027/S027 NUCLEUS 22 COCHLEAR, CORP. MODIFICATION TO THE
08/24/95 CHANNEL COCHLEAR NEGATIVE BATTERY
IMPLANT FOR USE ENGLEWOOD, CO TERMINAL ON THE
IN CHILDREN 80112 SPECTRA-22 AND
MINI SPEECH PROCESSORS
P890032/S018 CORDIS PTCA CORDIS, CORP. ALTERNATE
08/04/95 DILATATION STERILIZATION SITE
CATHETERS AND MIAMI, FL AND ELIMINATION OF
ORION STEERABLE 33102-5700 CHLOROFLUOROCARBONS
PTCA BALLOON FROM STERILIZATION
CATHETER PROCESS
P890043/S027 SIMPSON CORONARY GUIDANT, CORP. REVISED PRODUCT
08/17/95 ATHEROCATH LABELING
MODELS SCA-EX REDWOOD CITY, CA
(ALL SIZES) AND 94063
ATHEROCATH-GTO
(ALL SIZES)
P890047/S007 DUOVISC ALCON LABORATORIES, MODIFICATION TO THE
08/02/95 VISCOELASTIC INC. DUOVISC PACKAGE
SYSTEM FORT WORTH, TX INSERT TO ALLOW FOR
76134-2099 USE OF BOTH DEVICES
IN A SINGLE OPHTHALMIC
PROCEDURE
P900029/S001 QUICK CARE CIBA VISION, LABELING CHANGES
08/01/95 SYSTEM CORP. TO ENHANCE THE
DULUTH, GA INSTRUCTIONS TO BETTER
30136-1518 COMMUNICATE PROPER
LENS STORAGE TIMEFRAMES
P900056/S009 ROTABLATOR HEART TECHNOLOGY, CHANGE IN CONTRACT
08/14/95 ROTATIONAL INC. MANUFACTURER LOCATION
ANGIOPLASTY REDMOND, WA FOR SEAMED, CORP., FROM
SYSTEM 98052-3376 BOTHELL, WA TO
REDMOND, WA
P900059/S003 ALBUNEX MOLECULAR BIOSYSTEMS, CHANGE IN STERILIZATION
08/28/95 ULTRASOUND INC. PROCEDURE AND EQUIPMENT
CONTRAST SAN DIEGO, CA
MICROSPHERES 92121-2789
P900060/S006 CARBOMEDICS CARBOMEDICS, INC. REPLACEMENT OF THE
08/14/95 PROSTHETIC DEPYROGENATION OVENS
HEART VALVE AUSTIN, TX USED IN THE
(CPHV) 78752-1793 DEPYROGENATION PROCESS
OF THE CPHV
P900060/S009 CARBOMEDICS CARBOMEDICS, INC. USE OF A MODIFIED
08/14/95 PROSTHETIC VALVE HOLDER USED
HEART VALVE AUSTIN, TX AS AN ACCESSORY WITH
78752-1793 MODELS:A500, R500,
M700, AND S500
P900061/S008 MODEL 7219D MEDTRONIC, INC. APPROVAL FOR
08/22/95 JEWEL PCD AND MEDTRONIC, INC.,
MODEL 7202D JEWEL MINNEAPOLIS, MN BARRIO MARIANA,
CD 55432-3576 HUMACAO, PUERTO
RICO TO MANUFACTURE
MODEL 7219D JEWEL PCD
AND MODEL 7202D
JEWEL CD
P900061/S011 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR
08/01/95 IMPLANTABLE TECOTHANE 75D
CARDIOVERTER MINNEAPOLIS, MN POLYURETHANE RESIN
DEFIBRILLATOR 55432-3576 IN MEDTRONIC
(TECOTHANE 75D IMPLANTABLE
POLYURETHANE CARDIOVERTER
RESIN) DEFIBRILLATOR
P900061/S012 MODEL 7220 MEDTRONIC, INC. APPROVAL FOR
08/22/95 B/D/E JEWEL MEDTRONIC, INC.,
PLUS ARRHYTHMIA MINNEAPOLIS, MN PUERTO RICO, TO
CONTROL SYSTEM 55432-3576 MANUFACTURE MODEL
7220 B/D/E JEWEL
PLUS ARRHYTHMIA
CONTROL SYSTEM
P900061/S015 MEDTRONIC MEDTRONIC, INC. APPROVAL TO ELIMINATE
08/15/95 DEFIBRILLATION CFC TO MANUFACTURE
LEADS:MODELS 6921 MINNEAPOLIS, MN MODELS 6921 AND
AND 6721 55432-3576 6721 LEADS
EPICARDIAL LEADS
P900061/S016 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR MODEL
08/01/95 5420 PATIENT 5420 PATIENT CABLE TO
CABLE FOR MINNEAPOLIS, MN BE USED WITH MEDTRONIC,
IMPLANTABLE 55432-3576 INC'S IMPLANTABLE
DEFIBRILLATORS DEFIBRILLATORS
P910073/S007 VENTAK P2 AICD CARDIAC APPROVAL FOR MODELS
08/01/95 WITH ENDOTAK C PACEMAKERS, INC. 0070, 0072, AND 0074
0070, 0072, AND ST. PAUL, MN LEADS
0074 LEADS 55112-5798
P910073/S017 ENDOTAK LEAD MEDTRONIC, INC. APPROVAL FOR MODEL
08/03/95 SYSTEM MODEL 6946 LEAD REPAIR
6946 LEAD MINNEAPOLIS, MN KIT
REPAIR KIT 55432-3576
P910077/S004 PROGRAM DISK CARDIAC APPROVAL FOR PROGRAM
08/03/95 MODEL 2860 PACEMAKERS, INC. DISK MODEL 2860
REVISION 11.2 ST. PAUL, MN REVISION 11.2 SOFTWARE
SOFTWARE OF 55112-5798 OF VENTAK PRX AICD
VENTAK PRX SYSTEM
AICD SYSTEM
P920015/S004 TRANSVENE LEAD MEDTRONIC, INC. APPROVAL FOR
08/14/95 MODELS 6936, MODIFICATIONS TO THE
6933, AND 6939 MINNEAPOLIS, MN TRANSVENE LEAD
55432-3576 TECHNICAL MANUALS
P920015/S006 MEDTRONIC MEDTRONIC, INC. ELIMINATE CFC TO
08/17/95 DEFIBRILLATION MANUFACTURE THE
LEADS:TRANSVENE MINNEAPOLIS, MN REFERENCED
MODELS 6966, 55432-3576 DEFIBRILLATION
6936, 6963, AND LEADS
6933 AND MODELS
6939 AND 6999
PATCH LEADS
P920032/S001 MICRO-PACE PACE MEDICAL, INC. APPROVAL FOR MODELS
08/28/95 MODELS 4570, 4570, 4573, AND
4573, AND 4575 WALTHAM, MA 4575
DUAL CHAMBER, 02154
DDD, TEMPORARY
CARDIAC PACEMAKERS
P920047/S002 EPT-1000 EP TECHNOLOGIES, INC. APPROVAL FOR EPT-
08/14/95 CARDIAC 1000 GRAPHICS
ABLATION SUNNYVALE, CA SOFTWARE
SYSTEM 94086
P920047/S004 EPT-1000 EP TECHNOLOGIES, APPROVAL FOR
08/14/95 CARDIAC INC. RELOCATION OF CONTRACT
ABLATION SUNNYVALE, CA MANUFACTURE (SEAMED,
SYSTEM 94086 CORP.) WHO MANUFACTURES
EPT-1000 RF GENERATOR
Updated 11/18/1995
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