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PMA Final Decisions Rendered for May 1995 |
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.
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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