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PMA Final Decisions Rendered for June 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.
P940031 VIGOR DR PACEMAKER CPI/GUIDANT INDICATED FOR USE IN
06/21/95 SYSTEM/VIGOR SR LONG-TERM CARDIAC
PACEMAKER SYSTEM ST. PAUL, MN PACING
55112-5798
P950010 BOSTON SIMPLICITY POLYMER TECHNOLOGY INDICATED FOR CLEANING,
06/09/95 RINSING, DISINFECTING,
WILMINGTON, MA AND CONDITIONING FLUORO
01887 SILICONE ACRYLATE AND
SILICONE ACRYLATE RIGID
GAS PERMEABLE CONTACT
LENSES
N17755 /S042 ZIMMER DOUGH-TYPE ZIMMER, INC. MANUFACTURING SITE
06/09/95 AND ZIMMER L.V.C. FOR THE POWDER
LOW VISCOSITY WARSAW, IN COMPONENT AT ESSCHEM
BONE CEMENTS 46581-0708 CO., 4000 COLUMBIA
AVENUE, LINWOOD, PA.
N18466 /S016 CMW BONE CEMENT WRIGHT MEDICAL OPTIONAL PATIENT
06/21/95 TECHNOLOGY, INC. RECORD LABELLING TO
ARLINGTON, TN BE USED BY THE
38002 HOSPITAL IN RECORDING
THE USE OF CMW BONE
CEMENT
P790017/S056 VARIOUS USCI C.R. BARD, INC. REVISED LABELING;
06/12/95 BALLOON APPROVAL BASED ON
DILATATION BILLERICA, MA EXEMPTION FROM
CATHETERS 01821 APPLICATION INTEGRITY
POLICY
P800022/S023 ZYPLAST COLLAGEN COLLAGEN CORPORATION REVISIONS IN THE
06/16/95 IMPLANT & ZYDERM PHYSICIAN PACKAGE
COLLAGEN IMPLANT PAL ALTO, CA INSERTS
94303
P810046/S154 ACS RX ADVANCED NEW MODEL
06/14/95 LIFESTREAM CARDIOVASCULAR SYSTEMS ACS RX
CORONARY SANTA CLARA, CA LIFESTREAM
DILATATION 95052-8167 CORONARY
CATHETER W/10MM, DILATATION
QUARTER-SIZE/20MM CATHETER W/10MM,
AND 30MM LENGTHS QUARTER-SIZE/20MM
AND 30MM LENGTHS
P810046/S155 ACS CORONARY ADVANCED REVISED LABELING
06/07/95 BALLOON CARDIOVASCULAR SYSTEMS FOR ALL ACS
DILATATION SANTA CLARA, CA CORONARY BALLOON
CATHETERS 95052-8167 DILATATION
CATHETERS
P820021/S027 FOCUS TORIC CIBA VISION REVISED LABELING TO
06/28/95 (VIFILCON A) SOFT CORPORATION INCORPORATE
(HYDROPHILIC) DULUTH, GA MONOVISION FITTING
CONTACT LENSES 30136-1518 INFORMATION INTO THE
PRACTITIONER FITTING
GUIDE FOR PLANNED
REPLACEMENT
P820049/S059 PS-100A, 101A, ALLERGAN MEDICAL ALTERNATE
06/01/95 102A, 103A, 104A, OPTICS, INC. MANUFACTURING PROCESS
106A, 107A, 108A, IRVINE, CA AND ASSOCIATED
109A, 110A, 111A, 92718 LABELING CLAIMS
& PA-105A
DURALENS ULTRAVIO
LET-ABSORBING
PMMA POSTERIOR
CHAMBER
INTRAOCULAR LENSES
(IOLS)
P820083/S020 GORE-TEX EPTFE W.L. GORE & STEAM STERILIZATION
06/05/95 SUTURES ASSOCIATES, INC. AN ALTERNATE
FLAGSTAFF, AZ STERILIZATION METHOD
86003-2300 TO ETHYLENE OXIDE
(ET0)
P830033/S026 MODELS PCUB-30SEO SURGIDEV CORPORATION NEW MODELS:
06/05/95 & PCUB-32SEO PCUB-30SEO &
ULTRAVIOLET-ABSOR GOLETA, CA PCUB-32SEO
BING POSTERIOR 93117 ULTRAVIOLET-
CHAMBER ABSORBING
INTRAOCULAR POSTERIOR CHAMBER
LENSES INTRAOCULAR LENSES
P840068/S024 DELTA MODELS 936, CARDIAC ALTERNATE METHOD
06/05/95 937, & 938 - PACEMAKERS, INC. FOR BURN-IN OF THE
VISTA MODELS 443, BATTERIES
444, 445, 446, ST. PAUL, MN
447, 448, 449, 55112-5798
940, & 941 -
VIGOR MODELS 460,
465, 950, & 955
PACEMAKERS
P850021/S031 AMERICAN EDWARDS BAXTER HEALTHCARE REVISED LABELING
06/12/95 LABORATORIES CORPORATION FOR:SLINKY, INTREPID,
HYBRID SANTA ANA, CA REACH 14, LONG REACH
PERCUTANEOUS 92711-1150 30MM & 40MM, READY
TRANSLUMINAL 14, DISTANCE 14, LONG
CORONARY DISTANCE 30 & 40MM, &
ANGIOPLASTY GRAFT DISTANCE PTCA
(PTCA) CATHETERS CATHETERS
P860004/S033 MEDTRONIC MEDTRONIC NEUROLOGICAL ADDITIONAL WARNING
06/05/95 SYNCHROMED STATEMENTS ADDED TO
INFUSION SYSTEM MINNEAPOLIS, MN THE SYNCHROMED
55440-9087 INFUSION SYSTEM
TECHNICAL MANUALS
P860022/S046 BOSTON EQUALENS POLYMER TECHNOLOGY LABELING REVISIONS
06/05/95 RIGID GAS CORPORATION MADE TO STRENGTHEN
PERMEABLE CONTACT WILMINGTON, MA THE WARNINGS &
LENSES 01887 PRECAUTIONS FOR DAILY
& EXTENDED WEAR
P860022/S047 BOSTON EQUALENS POLYMER TECHNOLOGY LABELING REVISIONS
06/05/95 II RIGID GAS CORPORATION MADE TO STRENGTHEN
PERMEABLE CONTACT WILMINGTON, MA THE WARNINGS &
LENSES 01887 PRECAUTIONS FOR DAILY
AND EXTENDED WEAR
P860047/S009 OCUCOAT (2% HYDRO STORZ OPHTHALMICS, CHANGE IN TRADE
06/09/95 XYPROPYLMETHYCELL INC. NAME FROM OCCUCOAT
ULOSE SOLUTION) TO OCUCOAT
CLEARWATER, FL
34619
P880003/S042 SLEEK PTCA CORDIS CORPORATION REVISED LABELING
06/05/95 DILATATION
CATHETERS W/3CM MIAMI, FL
& 4CM BALLOONS 33102-5700
P880003/S043 PREDATOR PTCA CORDIS CORPORATION REVISED LABELING
06/05/95 DILATATION
CATHETER MIAMI, FL
33102-5700
P880003/S044 PREDATOR PTCA CORDIS CORPORATION REVISED LABELING
06/05/95 DILATATION
CATHETERS W/3CM MIAMI, FL
& 4CM BALLOONS 33102-5700
P880003/S045 TRAKSTAR 14 PTCA CORDIS CORPORATION REVISED LABELING
06/05/95 DILATATION
CATHETERS MIAMI, FL
33102-5700
P880027/S034 SHORTGOOSE SCHNEIDER (USA), INC. ADDITION OF SHORTENED
06/05/95 NONCOMPLIANT PTCA BALLOON LENGTHS TO
CATHETERS MINNEAPOLIS, MN THE MONGGOOSE PTCA
55442 CATHETER MARKETED
UNDER NEW TRADENAME
SCHNEIDER SHORTGOOSE
NONCOMPLIANT PTCA
CATHETER
P880086/S028 TRILOGY SIEMENS PACESETTER, NEW MODELS
06/07/95 MODELS:235OL DR, INC.
2308L DC, 225OL SYLMAR, CA
SR, PULSE 91392-9221
GENERATORS
P880086/S031 SYNCHRONY III & PACESETTER, INC. LABELING CHANGE TO
06/21/95 PARAGON III PULSE ADDRESS POTENTIAL FOR
GENERATOR SYLMAR, CA CROSSTALK
FAMILIES 91392-9221
P880098/S008 MENICON SF-P MENICON, INC. MODIFY LABELING FOR
06/23/95 (MELAFOCON A) THE PURPOSE OF ADDING
RIGID GAS WASHINGTON, D.C. OR STRENGTHENING THE
PERMEABLE CONTACT 20005 WARNING AND
LENS FOR DAILY & PRECAUTIONS
EXTENDED WEAR
P890034/S004 MODEL APT 1010 INFRASONICS, INC. REVISED SECONDARY
06/14/95 ULTRAHIGH FLOW SYSTEM, REMOVAL
FREQUENCY ROCKY HILL, CT OF ALARMS, INCLUSION
VENTILATOR 06067-3440 OF CLINICAL
ASSISTANCE NOMOGRAM
ON DISPLAY SCREEN,
PRE-OPERATIONAL TEST
DISPLAY SCREEN
P890043/S030 SIMPSON CORONARY DEVICES FOR VASCULAR ADD SMALL PEBAX
06/12/95 ATHEROCATH, INTERVENTION, INC. INSERT INSIDE BALLOON
ATHEROCATH-GTO REDWOOD CITY, CA LEG PRIOR TO
WITH MULTI-LAY 94063 LAMINATION, USE OF
NOSECONE, TECOFLEX 85A, MODIFY
ATHEROCATH-GTO, TORQUE CABLE CHANGES
ATHERCATH-GTO "THE DRIVESHAFT TO
GRAFT AND LARGE FILLET" DIMENSION
GRAFT SIZES
P890048/S004 USCI PROBE III C.R. BARD, INC. REVISED LABELING;
06/14/95 BALLOON-ON-A-WIRE APPROVAL BASED ON
DILATATION SYSTEM BILLERICA, MA EXEMPTION FROM
01821 APPLICATION INTEGRITY
POLICY
P890057/S004 MODEL 3100, 3100A SENSORMEDICS AUTHORIZATION OF
06/12/95 HIGH FREQUENCY CORPORATION SENSORMEDICS CORP AS
OSCILLATORY YORBA LINDA, CA ALTERNATIVE
VENTILATOR 92687 MANUFACTURING SITE FOR
2 PATIENT CIRCUIT
ASSEMBLIES & A BELLOWS/
WATER TRAP ASSEMBLY, & A
CAP/DIAPHRAGM
P890063/S004 THE GENESIS HOME CARELINK CORPORATION FIRMWARE CHANGES TO
06/16/95 UTERINE ACTIVITY INCREASE RELIABILITY
MONITORING SYSTEM SANTA ANA, CA AND BUILT-IN SYSTEM
92705 DIAGNOSTICS
P900023/S015 ABIOMED BVS 5000 ABIOMED, INC. CHANGE IN THE
06/22/95 BI-VENTRICULAR STERILIZATION CYCLE
SUPPORT SYSTEM DANVERS, MA
01923
P900061/S009 MEDTRONIC MODEL MEDTRONIC, INC. NEW MODEL:BEAD-
06/23/95 7220 B/D/E JEWEL BLASTED FINISH) WITH
PLUS ARRHYTHMIA MINNEAPOLIS, MN UPGRADED MODEL 9876E
CONTROL SYSTEM 55432-3576 SOFTWARE (SERIES 0 & 1)
(BEAD-BLASTED
FINISH) WITH
UPGRADED MODEL
9876E SOFTWARE
(SERIES 0 AND
SERIES 1)
P910031/S001 ENDOSONICS ORACLE ENDOSONICS CORPORATION NEW MODEL:ORACLE
06/05/95 MICRO PLUS PTCA MICRO PLUS PTCA
CATHETER RANCHO CORDOVA, CA CATHETER
95670
P910073/S014 ENDOTAK SQ LEAD CARDIAC PACEMAKERS, ALTERNATE
06/07/95 ARRAY MODEL 0048 INC. STERILIZATION PROCESS
ST. PAUL, MN USING OXYFUME 2000
55112-5798
P930029/S002 ATAKR RFCA SYSTEM MEDTRONIC CARDIORHYTHM ADDITION OF THE RF
06/23/95 MARINR NTC AND
SAN JOSE, CA ASSOCIATED CABLING TO
95134-1806 THE ATAKR RFCA SYSTEM
Updated 11/18/1996
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