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Medical Devices
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October 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for October 1995. 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
P930034/ SVS APEX SUMMIT TECHNOLOGY, INDICATED FOR A 6.0MM 10/20/95 (FORMERLY INC. ABLATION ZONE - MYOPIC OMNIMED) EXCIMER WALTHAM, MA PHOTOREFRACTIVE LASER SYSTEM FOR 02154 KERATECTOMY (PRK) PHOTREFRACTIVE FOR PATIENTS WHO KERATECTOMY (PRK) MEET SPECIFIC CRITERIA
PMA Supplement Approvals
N18073 /S024 SOFT MATE DAILY PILKINGTON ALTERNATE
10/31/95 CLEANING BARNES HIND STERILIZATION
SOLUTION, SOFT SUNNYVALE, CA FACILITY
MATE PS* DAILY 94086-5200 (CORONA, CA)
CLEANING
SOLUTION AND
SOFT MATE HANDS
OFF DAILY
CLEANER
N18078 /S049 SOFT MATE PILKINGTON ALTERNATE
10/31/95 SALINE BARNES HIND STERILIZATION
SOLUTION SUNNYVALE, CA FACILITY
94086-5200 (CORONA, CA)
P800018/S020 SOFT MATE PS PILKINGTON ALTERNATE
10/31/95 COMFORT DROPS, BARNES HIND STERILIZATION
SOFT MATE SUNNYVALE, CA FACILITY
COMFORT DROPS, 94086-5200 (CORONA, CA)
AND BARNES-HIND
GAS PERMEABLE
COMFORT DROPS
P820003/S070 MODEL 5348 MEDTRONIC, IN C. NEW MODELS:
10/31/95 TEMPORARY VITATRON MEP3000
PACEMAKER, MINNEAPOLIS, MN EXTERNAL PACEMAKER
VITATRON MEP3000 55432-3576 MODELS:5832, 5832S,
EXTERNAL 5433A, AND 5433V
PACEMAKER, MODEL CABLES, AND MODEL
5832, 5832S, 5101 ADAPTOR
5433A, AND 5433V
CABLES, AND MODEL
5101 ADAPTOR
P820018/S068 AUTIMA/AURORA TELECTRONICS PACING APPROVAL FOR THE
10/10/95 CARDIAC PACING SYSTEMS ADDITION OF A
SYSTEM:REFLEX DDD ENGLEWOOD, CO POLYAMIDE INSULATOR
MODELS 8224/8223E 80112 TO THE TELEMETRY COIL
& REFLEX MODELS
8218/8220E PULSE
GENERATORS,
SIMPLEX MODEL
8232 PULSE
GENERATOR
P820040/S032 PURE EYES CIBA VISION, CORP. MODIFICATIONS TO
10/23/95 DISINFECTANT/SOAK AOSEPT LENS CUP &
ING SOLUTION AND DULUTH, GA AODISC NEUTRALIZER
PURE EYES LENS 30136-1518 INCLUDING CHANGES IN
CASE WITH CUP MANUFACTURING
BUILT-IN SITE, CUP MATERIAL,
NEUTRALIZER CUP & DISC DESIGN, &
LABELING CHANGES
P820049/S060 MODELS PC-58NBM ALLERGAN MEDICAL TIER A MODIFICATIONS
10/18/95 AND PC-58NBZ, OPTICS OF A PREVIOUSLY
LOW-DIOPTER IRVINE, CA APPROVED ALLERGAN
ULTRAVIOLET-ABSOR 92713-9534 MEDICAL OPTICS LENS -
BING PMMA LENSES WILL BE
POSTERIOR CHAMBER OFFERED IN POWERS
INTRAOCULAR FROM -10.0 TP +5.5
LENSES (IOLS) DIOPTERS
P820075/S006 LAMICEL OSMOTIC MEROCEL CORPORATION APPROVAL FOR A NEW
10/10/95 CERVICAL DILATOR ACCELERATED TESTING
MYSTIC, CT PROTOCOL TO ESTABLISH
06355-0334 THE SHELF LIFE OF THE
PRODUCT TO 24 MONTHS
P830034/S026 ALCON ALCON LABORATORIES, MULTI-PURPOSE
10/31/95 MULTI-PURPOSE INC. SOLUTION ID 81573
SOLUTION ID 81573 FORT WORTH, TX SOLUTION FOR
76134-2099 CLEANING, RINSING,
DISINFECTING,
AND STORING SOFT
CONTACT LENSES
P830060/S040 CPI MODEL 6888 CARDIAC PACEMAKERS, MODEL 6888 LEAD
10/03/95 LEAD TUNNELER INC. TUNNELER
ST. PAUL, MN
55112-5798
P830061/S025 MEDTRONIC CAPSURE MEDTRONIC, INC. CHANGE IN
10/31/95 AND CAPSURE SP STERILIZATION PROCESS
PACING LEADS MINNEAPOLIS, MN FROM THE USE OF 12%
55432-3576 ETHYLENE OXIDE (ETO),
88% CFC, TO 100% ETO
P840001/S032 MEDTRONIC ITREL I MEDTRONIC NEUROLOGICAL ALTERNATE BEAD BLAST
10/17/95 AND II SCS FINISH
SYSTEMS MINNEAPOLIS, MN
55440-9087
P840008/S051 DORNIER DORNIER MEDICAL APPROVAL FOR
10/05/95 LITHOTRIPTER SYSTEMS TRANSPORTABLE VERSION
COMPACT KENNESAW, GA OF THE DORNIER
TRANSPORTABLE 30144 LITHOTRIPTER COMPACT
(DLCT) TRANSPORTABLE (DLCT)
P840008/S052 DORNIER DORNIER MEDICAL NEW MODEL
10/05/95 LITHOTRIPTER SYSTEMS, INC. LITHOTRIPTER
TRANSPORTABLE KENNESAW, GA INDICATED FOR
30144 FRAGMENTATION OF 5 TO
25 MILLIMETER KIDNEY
STONES SUCH AS RENAL
CALYX STONES AND
RENAL PELVIC STONES
P840040/S049 MEDI-TECH BOSTON SCIENTIFIC, REVISED LABELING
10/19/95 CORONARY BALLOON CORP. BASED ON FDA LTR
DILATATION NATICK, MA OF 1/7/95
CATHETER 01760-1537
P840040/S050 MEDI-TECH BOSTON SCIENTIFIC, REVISED LABELING
10/19/95 CORONARY BALLOON CORP.
DILATATION NATICK, MA
CATHETER 01760-1537
P840060/S025 MODEL MC50CD ALCON LABORATORIES, NEW MODEL:
10/05/95 ULTRAVIOLET-ABSOR INC. MC50CD UV
BING POSTERIOR FORT WORTH, TX ABSORBING
CHAMBER 76134-2099 POSTERIOR
INTRAOCULAR LENS CHAMBER IOL
P840066/S033 SOFT MATE PILKINGTON ALTERNATE
10/31/95 CONSEPT CLEANING BARNES HIND STERILIZATION
AND SUNNYVALE, CA FACILITY
DISINFECTING 94086-5200 (CORONA, CA)
SOLUTION
P850051/S051 MEDTRONIC PREVAIL MEDTRONIC, INC. APPROVAL FOR THE
10/31/95 PULSE GENERATORS ADDITION OF THREE
MODELS 8084, MINNEAPOLIS, MN MODELS OF PULSE
8085, AND 8086 55432-3576 GENERATORS TO THE
AND MODEL 9885 ACTVITRAX CARDIAC
SOFTWARE AND PACING SYSTEM
MODEL 9773
MEMORYMOD
P850089/S032 MEDTRONIC CAPSURE MEDTROIC, INC. APPROVAL FOR A CHANGE
10/31/95 AND CAPSURE SP IN THE STERILIZATION
PACING LEADS MINNEAPOLIS, MN PROCESS FOR THE USE
55432-3576 OF 12% ETHYLENE OXIDE
(ETO), 88% CFC, TO
100% ETO
P860019/S104 SCIMED PTCA SCIMED LIFE SYSTEMS, INDICATED FOR BALLOON
10/02/95 CATHETERS SCIMED INC. DILATATION OF THE
15MM NC BANDIT MAPLE GROVE, MN STENOTIC PORTION OF A
PTCA CATHETERS 55311-1566 CORONARY ARTERY OR
BYPASS GRAFT FOR THE
PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P860019/S105 SCIMED SCIMED LIFE SYSTEMS, MODIFIED EXPRESS
10/31/95 PERCUTANEOUS INC. PLUS II NEW MODELS:
TRANSLUMINAL MAPLE GROVE, MN NC EXPRESS PLUS AND
CORONARY 55311-1566 NC EXPRESS PLUS HD
ANGIOPLASTY
CATHETER SCIMED
NC EXPRESS PLUS
AND NC EXPRESS
PLUS HD PTCA
CATHETERS
P860019/S106 SCIMED SCIMED LIFE SYSTEMS, APPROVAL FOR THE
10/31/95 PERCUTANEOUS INC. ADDITION OF XTRA
TRANSLUMINAL MAPLE GROVE, MN SILICONE COATING TO
ANGIOPLASTY 55311-1566 THE POC BANDIT AND
CATHETER SCIMED BANDIT PTCA CATHETER
POC BANDIT AND LINES
BANDIT PTCA
CATHETERS
P860019/S107 SCIMED SCIMED LIFE SYSTEMS, ADDS QUARTER SIZED
10/31/95 PERCUTANEOUS INC. BALLOON DIAMETERS
TRANSLUMINAL MAPLE GROVE, MN AND ALTERNATE
CORONARY 55311-1566 COLORANT IN THE
ANGIOPLASTY BALLOON MANIFOLDS
CATHETER - SCIMED
LEAP EXPRESS PLUS
PTCA CATHETERS
P860061/S010 COMPLETE BRAND ALLERGAN APPROVAL FOR USE OF
10/11/95 WEEKLY ENZYMATIC DEVICE (SMALL TABLET
CLEANER IRVINE, CA FORMULATION) IN LENS
92713-9534 CASES WITH VOLUMES
RANGING FROM 1.8ML TO
4ML PER WELL
P870045/S039 ULTRAVIOLET CHIRON VISION, CORP. ALTERNATE
10/11/95 ABSORBING AND STERILIZATION CYCLE
NON-ULTRAVIOLET IRVINE, CA WITH REVISED
ABSORBING 92718-1903 PARAMETERS
POSTERIOR CHAMBER
INTRAOCULAR
LENSES
P880065/S002 MANSFIELD AORTIC BOSTON SCIENTIFIC, APPROVAL FOR A NEW
10/23/95 VALVULOPLASTY CORP. CONTRACT STERILIZER
BALLOON NATICK, MA AND A CHANGE IN THE
DILATATION 01760-1537 STERILIZATION
CATHETERS PROCEDURE
P890003/S037 MEDTRONIC MEDTRONIC, INC. REDUCED DEVICE
10/31/95 THERA-I/PRODIGY SIZE FOR THERA DR
PULSE GENERATORS, MINNEAPOLIS, MN MODEL. NEW TRADE
MODEL 9879 55432-3576 NAME:MEDTRONIC
SOFTWARE, AND THERA-I SERIES
MODELS 9759/9772
MEMORYMODS
P890003/S042 SYNERGYST II MEDTRONIC, INC. MODIFIED SOFTWARE
10/31/95 MODEL 9889E DISTRIBUTOR WILL
SOFTWARE MINNEAPOLIS, MN RELABEL TRIUMPH VR,
55432-3576 ELITE AS PRELUDE DR
AND SYNERGYST II AS
TRIUMPH DR
P890032/S022 CORDIS ORION CORDIS, CORP. ALTERNATE
10/31/95 STEERABLE PTCA STERILIZATION SITE
BALLOON CATHETER MIAMI, FL (ISOMEDIX
33102-5700 NORTHBOROUGH,
MASSACHUSETTS)
P900039/S008 COLLAGRAFT COLLAGEN, CORP. MODIFICATIONS TO THE
10/30/95 IMPLANT - PRODUCT LABELING
COLLAGRAFT STRIP PALO ALTO, CA PERTAINING TO
94303 POLYMYOSITIS/
DERMATOMYOSITIS
P900052/S002 PORT-A-CATH SIMS DELTEC, INC. MANUFACTURING
10/13/95 INTRASPINAL CHANGES: STERILIZATION
IMPLANTABLE ST. PAUL, MN PROCESS, PACKAGING,
ACCESS SYSTEM 55112 AND SHELF-LIFE DATING
P900060/S007 CARBOMEDICS CARBOMEDICS, INC. APPROVAL TO ADD AN
10/26/95 PROSTHETIC HEART ADDITIONAL
VALVE (CPHV), AUSTIN, TX STERILIZATION
MODELS A500, 78752-1793 PROTOCOL TO THE CPHV
R500, S500, M700, INSTRUMENTATION
AND S700 INSTRUCTIONS FOR USE
P910023/S008 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR CADENCE
10/31/95 THERAPY V-112 PULSE GENERATOR
DEFIBRILLATOR SUNNYVALE, CA SERIES (B, C, D, E)
SYSTEM 94086-6527 WITH PROGRAMMER
SOFTWARE VERSION 3.3
P910023/S011 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR THE
10/31/95 THERAPY PROGRAMMER SOFTWARE
DEFIBRILLATOR SUNNYVALE, CA VERSION 4.0 WITH THE
SYSTEM 94086-6527 CADENCE MODELS V-100,
V-110 OR V112
IMPLANTABLE
DEFIBRILLATOR
P910031/S002 CATHSCANNER ENDOSONICS, CORP. NEW MODEL FACT
10/03/95 ORACLE MICRO PTCA INDICATED FOR USE
CATHETER - FACT RANCHO CORDOVA, CA IN STENOTIC PORTION
BALLOON CORONARY 95670 CORONARY ARTERY OR
DILATATION BYPASS GRAFT STENOSIS
CATHETER
P910064/S012 REALITY FEMALE WISCONSIN PHARMACAL APPROVAL FOR CHANGES
10/05/95 CONDOM COMPANY, INC. IN THE LABELING "KEY
CHICAGO, IL ELEMENTS"
60611
P910066/S001 ORTHOLOGIC 1000 ORTHOLOGIC, CORP. REVISED LABELING:
10/31/95 BONE GROWTH SUCCESS RATES OBTAINED
STIMULATOR PHOENIX, AZ FROM PATIENT REGISTRY
85034
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