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PMA Final Decisions Rendered for January 1996 |
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.
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
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
Updated 7/23/1997
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