PMA Final Decisions Rendered for May 1995

Center for Devices and Radiological Health, U.S. Food and Drug Administration

PMA Final Decisions

Some of the documents PDF format and may not cannot access the documents link for assistance. Protocols (PDP), Supplement on a monthly basis.

A PDF of Safety and Effectiveness" The PMA number will about the Updated 4/http://www.fda.gov/default.htm">FDA | CDRH Home Page | Search harvest.gov/peth04/20041109234804/http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm">CDRH | Contact CDRH bb13509b"> coords="4,16,379,44" href="/peth04/20041109234804/http://www.fda.gov/default.htm" alt="U.S. Food and Drug Administration"> coords="8,55,374,69" href="/peth04/20041109234804/http://www.fda.gov/cdrh/index.html" alt="Center for Devices and Radiological Health"> bb0cb13c"> coords="0,0,0,3" href="#top" alt="[Skip navigation]"> 1109234804im_/http://www.fda.gov/cdrh/images/fdablackline.gif" alt="horizonal rule" width="100%" height="11" border="0"> --> Rendered for May 1995 align="right"> on this section of the CDRH Website are available only in be accessible to those with certain disabilities. If you you are interested in, please use the accessibility Below are Premarket Approvals (PMA), Product Development and Notice Decisions for May 1995. This list is generated document that contains the "Approval letter and Summary is being added to this listing for each PMA. appear as a link if this document is available. Information 0041109234804/http://www.fda.gov/cdrh/acrobat.html">PDF Reader is available. JOHNSON & JOHNSON DEVICE USED IN MEDICAL, INC. ENDOSCOPIC PROCEDURES ARLINGTON, TX 76004-3130 THE UPJOHN COMPANY REVISED CONTAINER LABELING KALAMAZOO, MI 49001-0199 COLLAGEN CORPORATION MODIFICATIONS TO PRODUCT LABELING PALO ALTO, CA RE:POLYMYOSITIS(PM)/ 94303 DERMATOMYOSITIS(DM) BAUSCH & LOMB 2 FLUID OUNCE (60ML) CONTAINER SIZE ROCHESTER, NY 14692-0450 PHARMACIA, INC. PROCEDURE THAT OPHTHALMICS REVISES THE 100% MONROVIA, CA INSPECTION RELEASE 91017-7136 CRITERIA WHICH CLASSIFIES THE DEFECTS FOR THE HEALON SODIUM HYALURONATE PRODUCTS ALCON LABORATORIES, MODELS:CF50BA, INC. CF57BA, CF60B2, FORT WORTH, TX MC20BA, MC20CM, 76134-2099 MC20C2, MC30BA, MC30CM, MC50RM, MC60BM, MC61BM, MZ60BA, SK51RM, SK60BM, SK61BM MEDTRONIC, INC. LABELING MODIFICATION TO PROVIDE MINNEAPOLIS, MN USER/PHYSICIAN W/INFO 55432-3576 RE:PATIENTS' USE OF CELLULAR PHONES IN PROXIMITY TO THEIR IMPLANTED PULSE GENERATOR SUNSOFT CORPORATION ALTERNATE MANUFACTURING SITE ALBUQUERQUE, NM FOR PRODUCTION OF THE 87109 DEVICE:SUNSOFT, CORP. 6815 ACADEMY PARKWAY WEST ALBUQUERQUE, NM 87109 SUNSOFT CORPORATION REVISED PROFESSIONAL FITTING GUIDE ALBUQUERQUE, NM 87109 SUNSOFT CORPORATION ALTERNATE MANUFACTURING PROCESS ALBUQUERQUE, NM COMBINING THE 87109 MOLDING/LATHING PROCESSES COOPERVISION, INC. ADD THE MONOVISION FITTING TECHNIQUE TO IRVINE, CA THE LABELING OF A 92718 SINGLE VISION CONTACT LENS TO MANAGE PRESBYOPIA ALLERGAN CHANGE IN PH AND OSMOLALITY TEST IRVINE, CA METHODS 92713 THERAKOS, INC. CHANGE IN LABELING FOR THE TK001 WEST CHESTER, PA PHOTOPHERESIS KIT AND 19380 THE UVAR INSTRUMENT DATA PLATE LABEL MEDTRONIC NEUROLOGICAL ADDITIONAL GRAPH TO BE ADDED TO THE MINNEAPOLIS, MN SYNCHROMED INFUSION 55440-9087 SYSTEM TECHNICAL MANUALS SCIMED LIFE SYSTEMS, NEW LINE OF OVER-THE INC. WIRE PTCA CATHETERS & MAPLE GROVE, MN MODIFICATIONS TO LEAP 55311-1566 TRIO 14 PTCA CATHETER SCIMED LIFE SYSTEMS, MODIFICATIONS TO THE INC. TRIO 14 PTCA CATHETER MAPLE GROVE, MN MODIFIED DEVICE WILL 55311-1566 BE MARKETED UNDER THE TRADE NAME:POC BANDIT SCIMED LIFE SYSTEMS, REVISED LABELING INC. MAPLE GROVE, MN 55311-1566 ALLERGAN OPTICAL ADDITIONAL ENZYME TABLET FORMULATION IRVINE, CA FOR THE ULTRAZYME 92713-9534 ENZYMATIC CLEANER MEDTRONIC NON-PIGMENTED INNER INTERVENTIONAL VASC LUMEN VERSION OF SAN DIEGO, CA PANTHER PTCA 92121-2256 CATHETERS SYVA COMPANY ADDITION OF AN AUTOMATED INSTRUMENT SAN JOSE, CA SYSTEM, THE MICRO 95161-9013 TRAK XL, FOR THE PERFORMANCE OF THE MICRO TRAK II HBEAG EIA SYVA COMPANY MICROTRAK II ANTI-HBE EIA FOR USE ON THE SAN JOSE, CA MICROTRAK XL 95161 INSTRUMENT BAXTER DIAGNOSTICS, LIMITATION STATEMENT INC. - MICROSCAN CONTRAINDICATING THE WEST SACRAMENTO, CA TESTING OF 95691 PNEUMOCOCCAL ISOLATES WITH MICROSCAN RAPID PANELS CORDIS CORPORATION REVISED LABELING MIAMI, FL 33102-5700 CORDIS CORPORATION REVISED LABELING MIAMI, FL 33102-5700 CORDIS CORPORATION REVISED LABELING MIAMI, FL 33102-5700 SCHNEIDER (USA), INC. REVISED LABELING PFIZER HOSPITAL PROD MINNEAPOLIS, MN 55442 STORZ OPHTHALMICS, LABELING CHANGES INC. CLEARWATER, FL 34619 MEDTRONIC, INC. LABELING MODIFICATION TO PROVIDE MINNEAPOLIS, MN USER/PHYSICIAN INFO 55432-3576 RE:PATIENTS USE OF CELLULAR PHONES IN PROXIMITY TO THE IMPLANTED PULSE GENERATOR SYVA COMPANY MICROTRACK II ANTI-HBE EIA FOR USE SAN JOSE, CA ON THE MICROTRAK X2 95161 INSTRUMENT COCHLEAR CORPORATION USE OF ALTERNATE HEADSET CABLES ENGLEWOOD, CO 80112 CORDIS CORPORATION REVISED LABELING MIAMI, FL 33102-5700 CARDIAC CONTROL VENDOR SUPPLIED SYSTEMS, INC. BATTERIES PALM COAST, FL MANUFACTURED BY 32164 ACCELERATED BURN-IN PROCESS C.R. BARD, INC. PLANNED MOVE OF PACKAGING EQUIPMENT BILLERICA, MA AND OPERATIONS FROM 01821 THE HAVERHILL FACILITY TO THE BILLERICA FACILITY ELA MEDICAL, INC. VENDOR SUPPLIED BATTERIES MINNETONK, MN MANUFACTURED BY 55345 ACCELERATED BURN-IN PROCESS HEART TECHNOLOGY, INC. ADDITION OF A 2.38MM BURR TO THE REDMOND, WA ROTABLATOR 98052-3376 ADVANCER/CATHETER BURR SIZES SPECTRANETICS MODIFICATION TO THE CORPORATION OPTICAL COUPLER OF COLORADO SPRINGS, CO THE EXTREME CATHETERS 80907 AND VITESSE-C II CATHETERS MED INSTITUTE, INC. A 12MM VERSION OF THE STENT AND REVISION WEST LAFAYETTE, IN OF INSTRUCTIONS FOR USE 47906 FOR THE 20MM VERSION CARDIAC PACEMAKERS, NEW MODELS INC. ENDOTAK C LEAD ST.PAUL, MN MODELS 0113 AND 0115 55112-5798 ALLERGAN OPTICAL APPROVAL FOR A 16FL OZ SIZE OF COMPLETE IRVINE, CA BRAND MULTI-PURPOSE 92713-9534 SOLUTION CARDIAC PACEMAKERS, NEW MODELS FOR THE INC. PULSE GENERATOR ST.PAUL, MN PROGRAMMED RECORDER 55112-5798 SOFTWARE, LEADS, PATCHES, CONNECTORS, ETC. EP TECHNOLOGIES, INC. ADDITION OF WARNING TO THE LABELING OF SUNNYVALE, CA THE STEEROCATH 94086 STEERABLE ABLATION CATHETER AND THE EPT-1000 CARDIAC ABLATION CONTROLLER, INSTRUCTIONS FOR USE MEDTRONIC CARDIORHYTHM LABELING CHANGES SAN JOSE, CA 95134-1806 MEDTRONIC CARDIORHYTHM ADDITION OF TRACKING NUMBERS TO THE SAN JOSE, CA PROXIMAL SHAFT OF ALL 95134-1806 ABLATR AND MARINR CATHETERS CARDIAC PACEMAKERS, ALTERNATE INC. STERILIZATION PROCESS ST. PAUL, MN USING OXYFUME 2000 55112 11/18/1995
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