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Medical Devices
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January 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for January 1996. 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
P940030 TECHNICON IMMUNO BAYER CORPORATION FOR QUANTITATIVE 01/30/96 1 CEA ASSAY MEASUREMENT OF SYSTEM TARRYTOWN, NY CARCINO EMBROYNIC 10591 ANTIGEN IN HUMAN SERUM FOR THE MANAGEMENT OF CANCER PATIENTS
PMA Supplement Approvals
N12159/S013 SURGICEL AND JOHNSON & JOHNSON 1)PROCESS CHANGE;
01/16/96 SURGICEL NU-KNIT MEDICAL, INC. 2)CHANGE OF IN-
ABSORBABLE ARLINGTON, TX PROCESS MANUFACTURING
HEMOSTAT 76004-3130 FACILITY; 3)CHANGE OF
QUALITY ASSURANCE
SITE; AND 4)ADDITION
OF ALTERNATE
STERILIZATION SITE
N17945/S029 ADAPETTES ALCON LABORATORIES ALTERNATE
01/04/96 LUBRICATING AND STERILIZATION
REWETTING FORT WORTH, TX METHOD WHICH USES
SOLUTION 76134-2099 100% ETHYLENE OXIDE
N17974/S049 PREFLEX ALCON LABORATORIES ALTERNATE
01/04/96 DAILY CLEANING STERILIZATION
SOLUTION FORT WORTH, TX METHOD WHICH USES
76134-2099 100% ETHYLENE OXIDE
N50510/S068 VITEK SYSTEMS BIOMERIEUX OFLOXACIN TO BE
01/17/96 "GENERAL VITEK, INC. INCLUDED ON THE GRAM
SUSCEPTIBILITY HAZELWOOD, MO NEGATIVE
CARD" 63042-2395 SUSCEPTIBILITY CARD
IN THREE
CONCENTRATIONS
(EQUIVALENT TO 1, 4,
AND 10 MCG/ML)
P790017/S057 USCI GRUNTZIG C.R. BARD, INC. REVISED LABELING
01/25/96 DILACA CORONARY
ARTERY & USCI BILLERICA, MA
XPRT WITH PRO/ 01821
PEL COATING
BALLOON
DILATATION
CATHETERS
P790018/S025 MEDTRONIC-HALL MEDTRONIC APPROVAL FOR THE 24MM
01/02/96 PROSTHETIC HEART CARDIAC SURGERY MEDTRONIC-HALL
VALVE MINNEAPOLIS, MN PROSTHETIC HEART
55440 VALVE, MODEL A7700
AHK
P800041/S015 CARBON TIP PACESETTER, INC. ADDITION OF A
01/04/96 CARDIAC PACING "NITROGEN BLANKET" TO
LEADS SYLMAR, CA STERILIZATION
93192-9221 PROCESS
P820036/S014 OPTI-CLEAN DAILY ALCON LABORATORIES, ALTERNATE
01/04/96 CLEANER INC. STERILIZATION
FORT WORTH, TX METHOD WHICH USES
76134-2099 100% ETHYLENE OXIDE
P820075/S007 LAMICEL MEROCEL, CORP. RELOCATION OF
01/03/96 OSMOSTIC CERVICAL CABOT'S LAMICEL
DILATOR MYSTIC, CT PROCESSING
06355-0334 EQUIPMENT AND THE
ASSOCIATED METHODS OR
PROCEDURES TO THE
MEROCEL FACILITY AT
MYSTIC, CT, 06355
P820076/S019 MODEL PMS 1000 BIOTRONIK, INC. APPROVAL FOR THE
01/24/96 PROGRAMMING AND MODEL PMS 1000
MONITORING SYSTEM LAKE OSWEGO, OR PROGRAMMING AND
WITH SOFTWARE 97035-5369 MONITORING SYSTEM
MODULE SWM 1000, WITH SOFTWARE MODULE
VERSION C01.C02.U SWM 1000, VERSION
C01.C02.U
P830033/S027 SINGLE-PIECE SURGIDEV, CORP. CHANGE IN VENDORS
01/29/96 AND THREE-PIECE WHO PROVIDE THE
ULTRAVIOLET- GOLETA, CA POLYMETHYLMETHA
ABSORBING 93117 CRYLATE (PMMA)
POSTERIOR CHAMBER MATERIAL
INTRAOCULAR
LENSES (IOLS)
P830037/S039 FRESHLOOK COLORS WESLEY-JESSEN INCORPORATION OF
01/25/96 UV AND FRESHLOOK AN ULTRA-VIOLET
LITETINT UV DES PLAINES, IL ABSORBER INTO THE
(PHEMFILCON A) 60018-5903 DEVICE
SOFT
(HYDROPHILIC)
CONTACT LENSES
P830055/S043 NEW JERSEY LCS DEPUY, INC. ADDITION OF GAS
01/02/96 TOTAL KNEE SYSTEM PLASMA STERILIZATION
WARSAW, IN FOR POLYETHYLENE
46581-0988 COMPONENTS
P840024/S058 NUCLEUS 22- COCHLEAR, CORP. MODIFICATION OF
01/24/96 CHANNEL COCHLEAR THERAPEUTIC CLAIMS OF
IMPLANT SYSTEM ENGLEWOOD, CO DEVICE EFFECTIVENESS
80112 FOR ADULT USERS
P840041/S006 NOVAFIL AND DAVIS & GECK REVISION OF THE
01/11/96 VASCUFIL EXISTING PACKAGE
POLYBUTESTER DANBURY, CT INSERTS, UNDER THE
MONOFILAMENT 06810 PROVISIONS OF
NONABSORBABLE 814.39(D)(1), SPECIAL
SURGICAL SUTURE PMA SUPPLEMENT-
CHANGES
P840051/S007 MAXON AND DAVIS & GECK REVISION OF THE
01/11/96 MAXON CV EXISTING PACKAGE
POLYGLYCONATE DANBURY, CT INSERTS, UNDER THE
MONOFILAMENT 06810 PROVISIONS OF
ABSORBABLE 814.39(D)(1), SPECIAL
SURGICAL SUTURE PMA SUPPLEMENT-
CHANGES
P850035/S018 EBI SPF ELECTRO-BIOLOGY, REVISIONS TO THE
01/16/96 IMPLANTABLE INC. PATIENT BROCHURE
SPINAL FUSION PARSIPPANY, NJ INCLUDING ADDITION
STIMULATOR 07054-1079 OF MRI WARNING AND
PRECAUTIONS
STATEMENT
P860057/S001 CARPENTIER- BAXTER HEALTHCARE TRADE NAME AND
01/04/96 EDWARDS CORP. DESIGN COMPONENT
PERICARDIAL SANTA ANA, CA CHANGES
BIOPROSTHESIS, 92711-1150
MODEL 2700
P870076/S001 FALOPE-RING CABOT MEDICAL, CHANGE OF
01/02/96 BAND AND CORP. STERILIZATION
APPLICATOR LANGHORNE, PA FACILITY TO THE
SYSTEM 19047 GRIFFITH MICROSCIENCE
FACILITY IN
WILLOWBROOK,
ILLINOIS
P880028/S006 DEXTRAN HM 32% ABBOTT ALTERNATE
01-04/96 HYSTEROSCOPIC LABORATORIES MANUFACTURING
DISTENTION ABBOTT PARK, IL FACILITY, ROQUETTE
MEDIUM 60064-3537 AMERICA, INC.,
KEOKUK, IOWA
P880047/S003 INTERCEED JOHNSON & JOHNSON ALTERNATE
01/18/96 ABSORBABLE MEDICAL, INC. STERILIZATION SITE,
ADHESION BARRIER ARLINGTON, TX AS WELL AS A NEW
76004-9962 MANUFACTURING SITE
FOR BULK ROLL OF
INTERCEED (TC7)
ABSORBABLE ADHESION
BARRIER
P880091/S005 ELASTIC LENS STARR SURGICAL CHANGE MOLDING
01/18/96 AND ELASTIMIDE COMPANY PARAMETERS
ULTRAVIOLET- MONROVIA, CA
ABSORBING 91016
SILICONE
POSTERIOR
CHAMBER
INTRAOCULAR
LENSES (IOLS)
P900023/S013 ABIOMED BVS ABIOMED, INC. INCREASE OF THE LEFT
01/29/96 5000 SIDE FLOW CAPACITY
BI-VENTRICULAR DANVERS, MA BY APPROXIMATELY
SUPPORT SYSTEM 01923 1 LITER/MINUTE
P900056/S011 ROTABLATOR HEART TECHNOLOGY, REMOVAL OF THE
01/18/96 ROTATIONAL INC. DRIVESHAFT DISTAL
ANGIOPLASTY REDMOND, WA HEATSHRINK
SYSTEM 98052-3376
P900056/S012 ROTABLATOR HEART TECHNOLOGY, APPROVAL FOR THE
01/29/96 ROTATIONAL INC. ROTAWIRE GUIDE WIRE
ANGIOPLASTY REDMOND, WA LINE
SYSTEM 98052-3376
P910016/S007 NEW JERSEY LCS DEPUY, INC. GAS PLASMA
01/02/96 TOTAL KNEE STERILIZATION FOR
SYSTEM WARSAW, IN POLYETHYLENE
46581-0988 COMPONENTS
P910031/S004 CATHSCANNER ENDOSONICS, CORP. APPROVAL FOR THE 25MM
01/18/96 ORACLE MICRO FACT CORONARY BALLOON
PTCA CATHETER RANCHO CORDOVA, CA DILATATION CATHETER
95670
P910031/S006 CATHSCANNER ENDOSONICS, CORP. ADDITIONAL
01/30/96 ORACLE MICRO MANUFACTURING
PTCA CATHETER RANCHO CORDOVA, CA SITE, IRVINE,
FACT BALLOON 95670 CA
CORONARY
DILATATION
CATHETER
P910058/S008 CHIROFLEX CHIRON VISION, DISTRIBUTION OF
01/02/96 MODEL C1OUB CORP. DEVICE BY ALLERGAN
ULTRAVIOLET- CLAREMONT, CA MEDICAL OPTICS
ABSORBING 91711 AS THE AMO SINGFLEX
SILICONE MODEL SI-14PB
POSTERIOR CHAMBER ULTRAVIOLET-
INTRAOCULER LENS ABOSRBING SILICONE
POSTERIOR CHAMBER IOL
P930031/S001 WALLSTENT TIPS SCHNEIDER (USA), ADDITION OF 10 MM
01/29/96 (TRANSJUGULAR INC. DIAMETER BY 94 MM
INTRAHEPATIC MINNEAPOLIS, MN LENGTH WALLSTENT TIPS
PORTOSYSTEMIC 55442 ENDOPROSTHESIS
SHUNT)
ENDOPROSTHESIS
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