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Medical Devices
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September 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 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 Original Approvals
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
PMA Supplement Approvals
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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