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Medical Devices
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May 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for May 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 Supplement Approvals
N12159 /S014 SURGICEL JOHNSON & JOHNSON DEVICE USED IN
05/12/95 ABSORBABLE MEDICAL, INC. ENDOSCOPIC PROCEDURES
HEMOSTAT AND ARLINGTON, TX
SURGICEL NU-KNIT 76004-3130
ABSORBABLE
HEMOSTAT
N18286 /S008 GELFOAM STERILE THE UPJOHN COMPANY REVISED CONTAINER
05/16/95 SPONGE PRODUCTS LABELING
KALAMAZOO, MI
49001-0199
P800022/S046 ZYPLAST AND COLLAGEN CORPORATION MODIFICATIONS TO
05/24/95 ZYDERM COLLAGEN PRODUCT LABELING
IMPLANT PALO ALTO, CA RE:POLYMYOSITIS(PM)/
94303 DERMATOMYOSITIS(DM)
P800024/S017 BAUSCH & LOMB BAUSCH & LOMB 2 FLUID OUNCE (60ML)
05/05/95 SENSITIVE EYES CONTAINER SIZE
PLUS SALINE ROCHESTER, NY
SOLUTION 14692-0450
P810031/S019 HEALON PHARMACIA, INC. PROCEDURE THAT
05/03/95 OPHTHALMICS REVISES THE 100%
MONROVIA, CA INSPECTION RELEASE
91017-7136 CRITERIA WHICH
CLASSIFIES THE
DEFECTS FOR THE
HEALON SODIUM
HYALURONATE PRODUCTS
P810032/S045 ULTRAVIOLET-ABOSO ALCON LABORATORIES, MODELS:CF50BA,
05/01/95 RBING POSTERIOR INC. CF57BA, CF60B2,
CHAMBER FORT WORTH, TX MC20BA, MC20CM,
INTRAOCULAR 76134-2099 MC20C2, MC30BA,
LENSES MC30CM, MC50RM,
MC60BM, MC61BM,
MZ60BA, SK51RM,
SK60BM, SK61BM
P850051/S050 LEGEND, LEGEND MEDTRONIC, INC. LABELING MODIFICATION
05/23/95 II, MICRO MINIX, TO PROVIDE
CPI TRIUMPH VR, MINNEAPOLIS, MN USER/PHYSICIAN W/INFO
AND VITATRON 55432-3576 RE:PATIENTS' USE OF
LEGACY SR PACING CELLULAR PHONES IN
SYSTEMS PROXIMITY TO THEIR
IMPLANTED PULSE
GENERATOR
P850077/S018 REVOLUTION SUNSOFT CORPORATION ALTERNATE
05/05/95 ASPHERIC MANUFACTURING SITE
MULTIFOCAL ALBUQUERQUE, NM FOR PRODUCTION OF THE
(METHAFILCON A) 87109 DEVICE:SUNSOFT, CORP.
SOFT 6815 ACADEMY PARKWAY
(HYDROPHILIC) WEST ALBUQUERQUE, NM
CONTACT LENS 87109
P850077/S020 SUNSOFT SUNSOFT CORPORATION REVISED PROFESSIONAL
05/05/95 (METHAFILCON A) FITTING GUIDE
SOFT ALBUQUERQUE, NM
(HYDROPHILIC) 87109
CONTACT LENS
P850077/S021 PROFILS ASPHERIC SUNSOFT CORPORATION ALTERNATE
05/25/95 MULTIFOCAL AND MANUFACTURING PROCESS
MULTIPLES TORIC ALBUQUERQUE, NM COMBINING THE
(METHAFILCON A) 87109 MOLDING/LATHING
SOFT (HYDROPHILIC) PROCESSES
CONTACT LENSES
(HYDROPHILIC)
CONTACT LENSES
P850079/S026 HYDRASOFT, COOPERVISION, INC. ADD THE MONOVISION
05/15/95 HYDRASOFT XW, FITTING TECHNIQUE TO
HYDRASOFT TORIC, IRVINE, CA THE LABELING OF A
HYDRASOFT TORIC 92718 SINGLE VISION CONTACT
XW, HYDROPHILIC LENS TO MANAGE
CONTACT LENSES PRESBYOPIA
P850088/S032 ULTRACARE ALLERGAN CHANGE IN PH AND
05/15/95 NEUTRALIZING OSMOLALITY TEST
TABLETS, IRVINE, CA METHODS
ULTRACARE 92713
NEUTRALIZING
TABLETS WITH
COLOR INDICATOR
P860003/S024 THERAKOS UVAR THERAKOS, INC. CHANGE IN LABELING
05/18/95 PHOTOPHERESIS FOR THE TK001
SYSTEM WEST CHESTER, PA PHOTOPHERESIS KIT AND
19380 THE UVAR INSTRUMENT
DATA PLATE LABEL
P860004/S034 MEDTRONIC MEDTRONIC NEUROLOGICAL ADDITIONAL GRAPH TO
05/22/95 SYNCHROMED BE ADDED TO THE
INFUSION SYSTEM MINNEAPOLIS, MN SYNCHROMED INFUSION
55440-9087 SYSTEM TECHNICAL
MANUALS
P860019/S097 SCIMED PTCA SCIMED LIFE SYSTEMS, NEW LINE OF OVER-THE
05/16/95 CATHETERS BANDIT, INC. WIRE PTCA CATHETERS &
LONG BANDIT 30, MAPLE GROVE, MN MODIFICATIONS TO LEAP
AND LONG BANDIT 55311-1566 TRIO 14 PTCA CATHETER
40 PTCA CATHETERS
P860019/S098 SCIMED PTCA SCIMED LIFE SYSTEMS, MODIFICATIONS TO THE
05/16/95 CATHETERS INC. TRIO 14 PTCA CATHETER
MAPLE GROVE, MN MODIFIED DEVICE WILL
55311-1566 BE MARKETED UNDER THE
TRADE NAME:POC BANDIT
P860019/S099 SCIMED PTCA SCIMED LIFE SYSTEMS, REVISED LABELING
05/16/95 CATHETERS INC.
MAPLE GROVE, MN
55311-1566
P860061/S009 COMPLETE BRAND ALLERGAN OPTICAL ADDITIONAL ENZYME
05/25/95 WEEKLY ENZYMATIC TABLET FORMULATION
CLEANER IRVINE, CA FOR THE ULTRAZYME
92713-9534 ENZYMATIC CLEANER
P870036/S034 MEDTRONIC MEDTRONIC NON-PIGMENTED INNER
05/16/95 PANTHER, PANTHER INTERVENTIONAL VASC LUMEN VERSION OF
30, & PANTHER 40 SAN DIEGO, CA PANTHER PTCA
CORONARY BALLOON 92121-2256 CATHETERS
DILATATION
CATHETERS
P870048/S006 MICROTRAK II SYVA COMPANY ADDITION OF AN
05/10/95 HBEAG EIA AUTOMATED INSTRUMENT
SAN JOSE, CA SYSTEM, THE MICRO
95161-9013 TRAK XL, FOR THE
PERFORMANCE OF THE
MICRO TRAK II HBEAG
EIA
P870048/S007 MICROTRAK II SYVA COMPANY MICROTRAK II ANTI-HBE
05/10/95 ANTI-HBE EIA FOR EIA FOR USE ON THE
USE ON THE SAN JOSE, CA MICROTRAK XL
MICROTRAK XL 95161 INSTRUMENT
INSTRUMENT
P870049/S023 MICROSCAN RAPID BAXTER DIAGNOSTICS, LIMITATION STATEMENT
05/05/95 FLUORGENIC GRAM INC. - MICROSCAN CONTRAINDICATING THE
POSITIVE PANELS WEST SACRAMENTO, CA TESTING OF
95691 PNEUMOCOCCAL ISOLATES
WITH MICROSCAN RAPID
PANELS
P880003/S041 WORLDPASS PTCA CORDIS CORPORATION REVISED LABELING
05/17/95 DILATATION
CATHETER MIAMI, FL
33102-5700
P880003/S046 SLEEK PTCA CORDIS CORPORATION REVISED LABELING
05/22/95 DILATATION
CATHETER MIAMI, FL
33102-5700
P880003/S047 OLYMPIX & SLEUTH CORDIS CORPORATION REVISED LABELING
05/22/95 XT PTCA
DILATATION MIAMI, FL
CATHETERS 33102-5700
P80027/S035 SCHNEIDER SCHNEIDER (USA), INC. REVISED LABELING
05/16/95 MC RAIL 20/30/40, PFIZER HOSPITAL PROD
MYSTIC MC MINNEAPOLIS, MN
20/30/40, FORTE18, 55442
FORTE30,MAGNARAIL
FREEHAND, MYSTIC
MONGOOSE, &
MAGNUM-MEIER PTCA
CATHETERS
P880090/S010 STORZ MODEL 121UV STORZ OPHTHALMICS, LABELING CHANGES
05/22/95 & 121UV INC.
UV-ABSORBING CLEARWATER, FL
ANTERIOR CHAMBER 34619
INTRAOCULAR LENS
P890003/S038 ELITE, ELITE II, MEDTRONIC, INC. LABELING MODIFICATION
05/23/95 MINUET, CPI TO PROVIDE
PRELUDE DR, CPI MINNEAPOLIS, MN USER/PHYSICIAN INFO
TRIUMPH DR, 55432-3576 RE:PATIENTS USE OF
VITATRON LEGACY CELLULAR PHONES IN
DR, VITATRON PROXIMITY TO THE
LEGACY D, THERA IMPLANTED PULSE
DR, THERA D, GENERATOR
THERA SR, & THERA
S
P890019/S004 MICROTRAK II SYVA COMPANY MICROTRACK II
05/10/95 TOTAL ANTI-HAV ANTI-HBE EIA FOR USE
EIA FOR USE ON SAN JOSE, CA ON THE MICROTRAK X2
THE MICROTRAK XL 95161 INSTRUMENT
INSTRUMENT
P890027/S023 NUCLEUS 22 COCHLEAR CORPORATION USE OF ALTERNATE
05/15/95 CHANNEL COCHLEAR HEADSET CABLES
IMPLANT FOR USE ENGLEWOOD, CO
WITH 80112
POSTLINGUISTICALL
Y PROFOUNDLY
DEAFENED CHILDREN
AGES 2-18
P890032/S021 CORDIS ORION CORDIS CORPORATION REVISED LABELING
05/17/95 STEERABLE PTCA
BALLOON MIAMI, FL
CATHETER-CORDIS 33102-5700
LIGHTNING
STEERABLE PTCA
BALLOON CATHETERS
P890039/S014 MAESTRO II SAVVI CARDIAC CONTROL VENDOR SUPPLIED
05/16/95 PACING SYSTEM SYSTEMS, INC. BATTERIES
MODELS 325 & 333 PALM COAST, FL MANUFACTURED BY
32164 ACCELERATED BURN-IN
PROCESS
P890048/003 USCI PROBE III C.R. BARD, INC. PLANNED MOVE OF
05/17/95 BALLOON-ON-A-WIRE PACKAGING EQUIPMENT
DILATATION SYSTEM BILLERICA, MA AND OPERATIONS FROM
01821 THE HAVERHILL
FACILITY TO THE
BILLERICA FACILITY
P900022/S004 CHORUS II DDD ELA MEDICAL, INC. VENDOR SUPPLIED
05/16/95 PACING SYSTEM BATTERIES
MODELS 6001, MINNETONK, MN MANUFACTURED BY
6003, 6004, 6033, 55345 ACCELERATED BURN-IN
AND 6034 PROCESS
P900056/S008 ROTABLATOR HEART TECHNOLOGY, INC. ADDITION OF A 2.38MM
05/22/95 ROTATIONAL BURR TO THE
ANGIOPLASTY REDMOND, WA ROTABLATOR
SYSTEM 98052-3376 ADVANCER/CATHETER
BURR SIZES
P910001/S010 EXTREME CATHETERS SPECTRANETICS MODIFICATION TO THE
05/16/95 (MDLS 114-006, CORPORATION OPTICAL COUPLER OF
117-009, 120-006), COLORADO SPRINGS, CO THE EXTREME CATHETERS
VITESSE-C II 80907 AND VITESSE-C II
CATHETERS (MDLS CATHETERS
114-007, 117-010,
120-007)
P910030/S003 GIANTURCO-ROUBIN MED INSTITUTE, INC. A 12MM VERSION OF
05/17/95 FLEX-STENT THE STENT AND REVISION
CORONARY STENT WEST LAFAYETTE, IN OF INSTRUCTIONS FOR USE
(12MM LENGTH) 47906 FOR THE 20MM VERSION
P910073/S013 ENDOTAK C LEAD CARDIAC PACEMAKERS, NEW MODELS
05/16/95 MODELS 0113 & INC. ENDOTAK C LEAD
0115 ST.PAUL, MN MODELS 0113 AND 0115
55112-5798
P910075/S003 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR A 16FL
05/15/95 MULTI-PURPOSE OZ SIZE OF COMPLETE
SOLUTION IRVINE, CA BRAND MULTI-PURPOSE
92713-9534 SOLUTION
P910077/S002 VENTAK PRX III CARDIAC PACEMAKERS, NEW MODELS FOR THE
05/02/95 AICD SYSTEM - INC. PULSE GENERATOR
ST.PAUL, MN PROGRAMMED RECORDER
55112-5798 SOFTWARE, LEADS,
PATCHES, CONNECTORS,
ETC.
P920047/S005 STEEROCATH EP TECHNOLOGIES, INC. ADDITION OF WARNING
05/16/95 STEERABLE TO THE LABELING OF
ABLATION CATHETER SUNNYVALE, CA THE STEEROCATH
AND EPT-1000 94086 STEERABLE ABLATION
CATHETER AND THE
EPT-1000 CARDIAC
ABLATION CONTROLLER,
INSTRUCTIONS FOR USE
P930029/S001 ATAKR RADIO MEDTRONIC CARDIORHYTHM LABELING CHANGES
05/17/95 FREQUENCY
CATHETER ABLATION SAN JOSE, CA
(RFCA) SYSTEM 95134-1806
P930029/S003 ATAKR RFCA SYSTEM MEDTRONIC CARDIORHYTHM ADDITION OF TRACKING
05/25/95 NUMBERS TO THE
SAN JOSE, CA PROXIMAL SHAFT OF ALL
95134-1806 ABLATR AND MARINR
CATHETERS
P930035/S002 VENTAK P2 AICD CARDIAC PACEMAKERS, ALTERNATE
05/25/95 SYSTEM INC. STERILIZATION PROCESS
ST. PAUL, MN USING OXYFUME 2000
55112
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