PMA Final Decisions Rendered for October 1995

A PDF of Safety and Effectiveness" The PMA number will about the P930034/ 10/20/95 (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTREFRACTIVE KERATECTOMY (PRK)

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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 October 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 20041109234556/http://www.fda.gov/cdrh/acrobat.html">PDF Reader is available. SVS APEX SUMMIT TECHNOLOGY, INDICATED FOR A 6.0MM INC. ABLATION ZONE - MYOPIC WALTHAM, MA PHOTOREFRACTIVE 02154 KERATECTOMY (PRK) FOR PATIENTS WHO MEET SPECIFIC CRITERIA PILKINGTON ALTERNATE BARNES HIND STERILIZATION SUNNYVALE, CA FACILITY 94086-5200 (CORONA, CA) PILKINGTON ALTERNATE BARNES HIND STERILIZATION SUNNYVALE, CA FACILITY 94086-5200 (CORONA, CA) PILKINGTON ALTERNATE BARNES HIND STERILIZATION SUNNYVALE, CA FACILITY 94086-5200 (CORONA, CA) MEDTRONIC, IN C. NEW MODELS: VITATRON MEP3000 MINNEAPOLIS, MN EXTERNAL PACEMAKER 55432-3576 MODELS:5832, 5832S, 5433A, AND 5433V CABLES, AND MODEL 5101 ADAPTOR TELECTRONICS PACING APPROVAL FOR THE SYSTEMS ADDITION OF A ENGLEWOOD, CO POLYAMIDE INSULATOR 80112 TO THE TELEMETRY COIL CIBA VISION, CORP. MODIFICATIONS TO AOSEPT LENS CUP & DULUTH, GA AODISC NEUTRALIZER 30136-1518 INCLUDING CHANGES IN CUP MANUFACTURING SITE, CUP MATERIAL, CUP & DISC DESIGN, & LABELING CHANGES ALLERGAN MEDICAL TIER A MODIFICATIONS OPTICS OF A PREVIOUSLY IRVINE, CA APPROVED ALLERGAN 92713-9534 MEDICAL OPTICS LENS - LENSES WILL BE OFFERED IN POWERS FROM -10.0 TP +5.5 DIOPTERS MEROCEL CORPORATION APPROVAL FOR A NEW ACCELERATED TESTING MYSTIC, CT PROTOCOL TO ESTABLISH 06355-0334 THE SHELF LIFE OF THE PRODUCT TO 24 MONTHS ALCON LABORATORIES, MULTI-PURPOSE INC. SOLUTION ID 81573 FORT WORTH, TX SOLUTION FOR 76134-2099 CLEANING, RINSING, DISINFECTING, AND STORING SOFT CONTACT LENSES CARDIAC PACEMAKERS, MODEL 6888 LEAD INC. TUNNELER ST. PAUL, MN 55112-5798 MEDTRONIC, INC. CHANGE IN STERILIZATION PROCESS MINNEAPOLIS, MN FROM THE USE OF 12% 55432-3576 ETHYLENE OXIDE (ETO), 88% CFC, TO 100% ETO MEDTRONIC NEUROLOGICAL ALTERNATE BEAD BLAST FINISH MINNEAPOLIS, MN 55440-9087 DORNIER MEDICAL APPROVAL FOR SYSTEMS TRANSPORTABLE VERSION KENNESAW, GA OF THE DORNIER 30144 LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) DORNIER MEDICAL NEW MODEL SYSTEMS, INC. LITHOTRIPTER KENNESAW, GA INDICATED FOR 30144 FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES BOSTON SCIENTIFIC, REVISED LABELING CORP. BASED ON FDA LTR NATICK, MA OF 1/7/95 01760-1537 BOSTON SCIENTIFIC, REVISED LABELING CORP. NATICK, MA 01760-1537 ALCON LABORATORIES, NEW MODEL: INC. MC50CD UV FORT WORTH, TX ABSORBING 76134-2099 POSTERIOR CHAMBER IOL PILKINGTON ALTERNATE BARNES HIND STERILIZATION SUNNYVALE, CA FACILITY 94086-5200 (CORONA, CA) MEDTRONIC, INC. APPROVAL FOR THE ADDITION OF THREE MINNEAPOLIS, MN MODELS OF PULSE 55432-3576 GENERATORS TO THE ACTVITRAX CARDIAC PACING SYSTEM MEDTROIC, INC. APPROVAL FOR A CHANGE IN THE STERILIZATION MINNEAPOLIS, MN PROCESS FOR THE USE 55432-3576 OF 12% ETHYLENE OXIDE (ETO), 88% CFC, TO 100% ETO SCIMED LIFE SYSTEMS, INDICATED FOR BALLOON INC. DILATATION OF THE MAPLE GROVE, MN STENOTIC PORTION OF A 55311-1566 CORONARY ARTERY OR BYPASS GRAFT FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION SCIMED LIFE SYSTEMS, MODIFIED EXPRESS INC. PLUS II NEW MODELS: MAPLE GROVE, MN NC EXPRESS PLUS AND 55311-1566 NC EXPRESS PLUS HD SCIMED LIFE SYSTEMS, APPROVAL FOR THE INC. ADDITION OF XTRA MAPLE GROVE, MN SILICONE COATING TO 55311-1566 THE POC BANDIT AND BANDIT PTCA CATHETER LINES SCIMED LIFE SYSTEMS, ADDS QUARTER SIZED INC. BALLOON DIAMETERS MAPLE GROVE, MN AND ALTERNATE 55311-1566 COLORANT IN THE BALLOON MANIFOLDS ALLERGAN APPROVAL FOR USE OF DEVICE (SMALL TABLET IRVINE, CA FORMULATION) IN LENS 92713-9534 CASES WITH VOLUMES RANGING FROM 1.8ML TO 4ML PER WELL CHIRON VISION, CORP. ALTERNATE STERILIZATION CYCLE IRVINE, CA WITH REVISED 92718-1903 PARAMETERS BOSTON SCIENTIFIC, APPROVAL FOR A NEW CORP. CONTRACT STERILIZER NATICK, MA AND A CHANGE IN THE 01760-1537 STERILIZATION PROCEDURE MEDTRONIC, INC. REDUCED DEVICE SIZE FOR THERA DR MINNEAPOLIS, MN MODEL. NEW TRADE 55432-3576 NAME:MEDTRONIC THERA-I SERIES MEDTRONIC, INC. MODIFIED SOFTWARE DISTRIBUTOR WILL MINNEAPOLIS, MN RELABEL TRIUMPH VR, 55432-3576 ELITE AS PRELUDE DR AND SYNERGYST II AS TRIUMPH DR CORDIS, CORP. ALTERNATE STERILIZATION SITE MIAMI, FL (ISOMEDIX 33102-5700 NORTHBOROUGH, MASSACHUSETTS) COLLAGEN, CORP. MODIFICATIONS TO THE PRODUCT LABELING PALO ALTO, CA PERTAINING TO 94303 POLYMYOSITIS/ DERMATOMYOSITIS SIMS DELTEC, INC. MANUFACTURING CHANGES: STERILIZATION ST. PAUL, MN PROCESS, PACKAGING, 55112 AND SHELF-LIFE DATING CARBOMEDICS, INC. APPROVAL TO ADD AN ADDITIONAL AUSTIN, TX STERILIZATION 78752-1793 PROTOCOL TO THE CPHV INSTRUMENTATION INSTRUCTIONS FOR USE VENTRITEX, INC. APPROVAL FOR CADENCE V-112 PULSE GENERATOR SUNNYVALE, CA SERIES (B, C, D, E) 94086-6527 WITH PROGRAMMER SOFTWARE VERSION 3.3 VENTRITEX, INC. APPROVAL FOR THE PROGRAMMER SOFTWARE SUNNYVALE, CA VERSION 4.0 WITH THE 94086-6527 CADENCE MODELS V-100, V-110 OR V112 IMPLANTABLE DEFIBRILLATOR ENDOSONICS, CORP. NEW MODEL FACT INDICATED FOR USE RANCHO CORDOVA, CA IN STENOTIC PORTION 95670 CORONARY ARTERY OR BYPASS GRAFT STENOSIS WISCONSIN PHARMACAL APPROVAL FOR CHANGES COMPANY, INC. IN THE LABELING "KEY CHICAGO, IL ELEMENTS" 60611 ORTHOLOGIC, CORP. REVISED LABELING: SUCCESS RATES OBTAINED PHOENIX, AZ FROM PATIENT REGISTRY 85034 11/18/1995

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