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PMA Final Decisions Rendered for September 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.
P910062 VISX EXCIMER VISX, INC. INDICATED FOR 09/29/95 LASER SYSTEM PHOTOTHERAPEUTIC (MODELS B AND C) SANTA CLARA, CA KERATECTOMY (PTK) 95051-0703 P910063 CAREFONE HOME CARELINK, CORP. INDICATED FOR AT HOME 09/29/95 UTERINE ACTIVITY MEASUREMENT OF MONITORING SANTA ANA, CA UTERINE ACTIVITY SYSTEM, MODEL 92705-5700 2001 P920004 VASOSEAL VASCULAR DATASCOPE, CORP. FOR USE IN REDUCING 09/29/95 HEMOSTASIS DEVICE TIME TO HEMOSTASIS MONTVALE, NJ AT THE FEMORAL 07645 ARTERY PUNCTURE SITE AFTER PTCA P920006 ABBOTT PGR-ICA ABBOTT LABORATORIES INDICATED FOR 09/26/95 MONOCLONAL DETECTION OF HUMAN ABBOTT PARK, IL PROGESTERONE 60064 RECEPTOR (PGR) IN BREAST TUMOR TISSUE P920038 HEALTHDYNE SYSTEM HEALTHDYNE, INC. INDICATED FOR AT 09/29/95 37 HOME UTERINE HOME MEASUREMENT ACTIVITY MARIETTA, GA OF UTERINE MONITORING SYSTEM 30067 ACTIVITY P920048 FETAL FIBRONECTIN ADEZA BIOMEDICAL, INDICATED FOR USE 09/21/95 ENZYME CORP. TO AID IN ASSESSING IMMUNOASSAY KIT SUNNYVALE, CA THE RISK OF PRETERM 94089 DELIVERY P930012 PAS LACROSSE PTCA PROGRESSIVE INDICATED FOR 09/27/95 CATHETER (2.0MM, ANGIOPLASTY SYST, INC. BALLOON DILATATION 2.5MM, 3.0MM, MENLO PARK, CA OF CORONARY ARTERIES 3.5MM, & 4.0MM 94025-1516 TO IMPROVE MYOCARDIAL PERFUSION P930027 COAT-A-COUNT PSA DIAGNOSTIC PRODUCTS, INDICATED TO AID IN 09/15/95 IRMA CORP. THE MANAGEMENT OF LOS ANGELES, CA PROSTATE CANCER 90045 PATIENTS P930031/ WALLSTENT TIPS SCHNEIDER (USA), INC. INDICATED TO TREAT 09/29/95 (TRANSJUGULAR PORTAL HYPERTENSION INTRAHEPATIC MINNEAPOLIS, MN IN PATIENTS FAILING PORTOSYSTEMIC 55442 CONVENTIONAL THERAPY SHUNT) ENDOPROSTHESIS P930036 CIBA CORNING ACS CIBA CORNING INDICATED AS AN AID 09/29/95 AFP IMMUNOASSAY DIAGNOSTICS, CORP. IN DETECTION OF OPEN MEDFIELD, MA NEURAL TUBE DEFECTS 02052-1688 & IN MANAGING NON-SEMINOMATOUS TESTICULAR CANCER P950009 AUTOPAP 300 QC NEOPATH, INC. INDICATED FOR QUALITY 09/29/95 SYSTEM CONTROL OF PREVIOUSLY REDMOND, WA SCREENED PAP SMEAR 98052 SLIDES CLASSIFIED AS WITHIN NORMAL LIMITS
N17600 /S014 AVITENE MEDCHEM PRODUCTS, INC. ADDITION 09/14/95 MICROFIBRILLAR OF SPRAY DELIVERY COLLAGEN HEMOSTAT WOBURN, MA DEVICES FOR AVITENE (MCH) 01801 MICROFIBRILLAR COLLAGEN HEMOSTAT N17752 /S036 HYDROCURVE 3 PILKINGTON BARNES HIND ALTERNATE 09/22/95 TORIC(BUFILCON A) MANUFACTURING PROCESS SOFT(HYDROPHILIC) SUNNYVALE, CA USING ULTRAVIOLET CONTACT LENS FOR 94086 LIGHT INITIATOR IN EXTENDED WEAR, MODIFIED CURE PROCESS HYDROCURVE II EW, FOR BUFILCON A (55% HYDRROCURVE II WATER) CONTACT LENSES 55%, HYDROCURVE APHAKIC 55% SOFT MATE II N17945 /S028 ADAPETTES ALCON LABORATORIES, CHANGES 09/08/95 LUBRICATING AND INC. IN MANUFACTURING REWETTING FORT WORTH, TX PROCESS TO ELIMINATE SOLUTION 76134-2099 AIR BLOWING EMPTY BOTTLES AND INCLUDE SPECIFICATIONS TO CONTROL PARTICULATE LEVELS N17974 /S048 PREFLEX DAILY ALCON LABORATORIES, CHANGES 09/08/95 CLEANING SOLUTION INC. IN MANUFACTURING FORT WORTH, TX PROCESS TO ELIMINATE 76134-2099 AIR BLOWING EMPTY BOTTLES AND INCLUDE SPECIFICATIONS TO CONTROL PARTICULATE LEVELS N18020 /S040 LENS PLUS STERILE ALLERGAN REVISED 09/20/95 SALINE SOLUTION PACKAGE INSERT TO BE IRVINE, CA PRINTED ON THE 92713-9534 8FL.OZ. & 15FL.OZ. AEROSOL CANS AND ELIMINATE THE PACKAGE INSERT FOR THESE SIZE CONTAINERS N18331 /S026 PDS II ETHICON, INC. CHANGE 09/07/95 (POLYDIOXANONE) IN STERILIZATION SUTURE, DYED, AND SOMERVILLE, NJ PROCESS TO ETHYLENE UNDYED 08876-0151 OXIDE/OXYFUME GAS MIXTURE P800036/S015 INFUSAID MODEL STRATO/INFUSAID, INC. CHANGE IN LABELING 09/20/95 400 IMPLANTABLE ADDS EPIDURAL AND INFUSION PUMP FOR NORWOOD, MA INTRATHECAL THE DELIVERY OF 02062 ADMINISTRATION OF INFUMORPH 200 AND INFUMORPH 200 AND 500 CII 500 CII (PRESERVATIVE-FRE E MORPHINE SULFATE 10MG/ML AND 25MG/ML) P810006/S019 COLLASTAT VITAPHORE, CORP. ALTERNATE 09/12/95 MICROFIBRILLAR STERILIZATION HEMOSTATIC SPONGE PLAINSBORO, NJ FACILITY FOR 08536 COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE AT GLEN FALLS, NY 12801 P820036/S013 OPTI-CLEAN DAILY ALCON LABORATORIES, CHANGES 09/08/95 CLEANER INC. IN MANUFACTURING FORT WORTH, TX PROCESS TO ELIMINATE 76134-2099 AIR BLOWING EMPTY BOTTLES AND INCLUDE SPECIFICATIONS TO CONTROL PARTICULATE LEVELS P820076/S017 PMS 600 BIOTRONIK, INC. APPROVAL FOR THE SWM 09/07/95 PROGRAMMER WITH 600 VERSION DO5UO1 SWM 600 VERSION LAKE OSWEGO, OR SOFTWARE MODULE FOR DO5UO1 SOFTWARE 97035-5369 USE WITH THE MODEL MODULE PMS 600 PROGRAMMER P830034/S027 OPTI-ONE ALCON LABORATORIES, EXPAND THE INDICATIONS 09/26/95 MULTI-PURPOSE INC. FOR USE TO ALL CLEAR SOLUTION FORT WORTH, TX AND TINTED DAILY AND 76134-2099 CONTACT LENSES P830034/S028 OPTI-CLEAN II ALCON LABORATORIES, CHANGES 09/08/95 DAILY CLEANER, INC. IN MANUFACTURING OPTI-FREE DAILY FORT WORTH, TX PROCESS TO ELIMINATE CLEANER, 76134-2099 AIR BLOWING OF EMPTY OPTI-FREE BOTTLES AND INCLUDE REWETTING DROPS, SPECIFICATIONS TO OPTI-TEARS CONTROL PARTICULATE SOOTHING DROPS LEVELS P840062/S006 COLLACOTE, COLLA-TEC, INC. ALTERNATE 09/08/95 COLLATAPE, AND STERILIZATION COLLAPLUG PLAINSBORO, NJ FACILITY AT GLEN DRESSINGS 08536 FALLS, NY 12801 P850010/S015 HELISTAT COLLA-TEC, INC. ALTERNATE 09/12/95 ABSORBABLE STERILIZATION COLLAGEN PLAINSBORO, NJ FACILITY FOR HELISTAT HEMOSTATIC AGENT 08536 ABSORBABLE COLLAGEN HEMOSTATIC AGENT AT GLEN FALLS, NY 12801 P850057/S005 SOFTMATE PILKINGTON BARNES HIND ALTERNATE 09/22/95 CUSTOMEYES MANUFACTURING PROCESS (BUFILCON A, 55% SUNNYVALE, CA USING ULTRAVIOLET WATER) SOFT 94086 LIGHT INITIATOR IN (HYDROPHILIC MODIFIED CURE PROCESS CONTACT LENS FOR FOR BUFILCON A (55% EXTENDED WEAR WATER) CONTACT LENSES P860027/S010 MAESTRO II MODEL CARDIAC CONTROL APPROVAL FOR THE 09/26/95 533 PACEMAKER SYSTEMS, INC. MAESTRO II MODEL 533 SYSTEM PALM COAST, FL PACEMAKER SYSTEM 32164 P870007/S009 SORBIC ACID OPTOPICS LABORATORIES, MODIFICATION OF THE 9/20/95 PRESERVED STERILE CORP. STABILITY SALINE FOR SOFT FAIRTON, NJ SPECIFICATIONS FOR CONTACT LENSES 08320 SORBIC ACID CONCENTRATION P870015/S021 MEDSTONE STS MEDSTONE ALTERNATE ULTRASOUND 09/15/95 EXTRACORPOREAL INTERNATIONAL, INC. IMAGING UNIT, SHOCK WAVE ALISO VIEJO, CA ALTERNATE DIGITIZER LITHOTRIPTER 92656-4114 PAD, MODIFIED SYSTEM SOFTWARE, REVISION TO USER'S MANUAL P880003/S049 CORDIS PTCA CORDIS, CORP. NEW PACKAGING 09/18/95 DILATATION TRAY MATERIAL CATHETERS MIAMI, FL (ACRYLIC XT 33102-5700 POLYMER) P880011/S003 SONOLITH 2000 EDAP TECHNOMED GROUP MANUFACTUING SITE 09/06/95 (USA), INC. CHANGE TO BRON, CAMBRIDGE, MA FRANCE TO MANUFACTURE 02139 THE SOLOLITH 2000 AND 3000 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTERS P880082/S018 INTRAOCULAR EYE TECHNOLOGY, INC. USE OF NEW CLEANING 09/28/95 LENSES AGENT ST. PAUL, MN 55117 P890057/S003 MODEL 3100/3100A SENSORMEDICS, CORP. INDICATED FOR THE 09/15/95 HIGH FREQUENCY TREATMENT OF NEONATES OSCILLATORY YORBA LINDA, CA WHO HAVE RESPIRATORY VENTILATOR 92687 FAILURE AND SELECTED PEDIATRIC PATIENTS WHO ARE FAILING CONVENTIONAL VENTILATION P930035/S001 VENTAK P3, MODELS CARDIAC PACEMAKERS, NEW SOFTWARE MODULES, 09/08/95 1630 AND 1635 INC. PATCH LEADS CONNECTORS, AICD SYSTEM ST.PAUL, MN AND ALTERNATE 55112-5798 STERILIZATION METHOD USING OXYFUME
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