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Medical Devices
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February 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 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
P910018 LIPOSORBER KANEKA AMERICA THE DEVICE IS A 02/21/96 LA-15 SYSTEM CORP. LOW DENSITY NEW YORK, NY LIPOPROTEIN (LDL) 10022 APHERESIS SYSTEM FOR CERTAIN HIGH RISK PATIENT POPULATIONS P950018 PERFLUORON INFINITECH, INC. THE DEVICE IS AN 02/29/96 (PURIFIED INTRAOPERATIVE TOOL PERFLUORO-N- CHESTERFIELD, MO FOR USE DURING OCTANE LIQUID) 63005 VITREORETINAL SURGERY IN PATIENTS WITH RETINAL DETACHMENTS
PMA Supplement Approvals
N12159/S015 SURGICEL JOHNSON & JOHNSON MANUFACTURING CHANGE
02/01/96 FIBRILLAR MEDICAL, INC. WHICH ADDS A STEP TO
ABSORBABLE ARLINGTON, TX FORM A FIBRILLAR
HEMOSTAT 76004-3130 STRUCTURE FOR THE
DEVICE
N17786/S025 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 HYDROCARE STERILIZATION SITE
CLEANING AND IRVINE, CA AND THE USE OF 100%
DISINFECTING 92713-9534 ETHYLENE OXIDE TO
SOLUTION STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
N18020/S041 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 HYDROCARE STERILIZATION SITE
PRESERVED SALINE IRVINE, CA AND THE USE OF 100%
SOLUTION 92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P790017/S049 BALLOON C.R. BARD, INC. MANUFACTURING CHANGES
02/26/96 DILATION TO THE BALLOON AND
CATHETERS BILLERICA, MA INCLUDE THE USE OF A
01821 BALLOON PROTECTOR;
NEW TRADE NAME
PET ELITE
P790024/S025 LC-65 DAILY ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 CLEANER STERILIZATION SITE
IRVINE, CA AND THE USE OF 100%
92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P790025/S007 ABBOTT HBE ABBOTT CHANGE IN
02/26/96 (RDNA) EIA LABORATORIES MANUFACTURING
TEST KIT ABBOTT PARK, IL PROCESS FOR BEAD
60064-3500 COATING
P800022/S048 ZYDERM I AND II COLLAGEN CORP. MANUFACTURING CHANGE
02/01/96 AND ZYPLAST
COLLAGEN IMPLANTS PALO ALTO, CA
94303
P800065/S015 LENS-WET ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 LUBRICATING STERILIZATION SITE
AND REWETTING IRVINE, CA AND THE USE OF 100%
SOLUTION 92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P810046/S158 ACS CONCORDE ADVANCED APPROVAL FOR ACS
02/05/96 CORONARY CARDIOVASCULAR CONCORDE CORONARY
DILATATION SANTA CLARA, CA DILATATION CATHETER
CATHETER 95052-8167
P810046/S159 ACS ENDURA ADVANCED APPROVAL FOR THE ACS
02/26/96 CORONARY CARDIOVASCULAR ENDURA CORONARY
DILATATION SANTA CLARA, CA DILATATION CATHETER
CATHETER 95052-8167
P840024/S055 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS
02/13/96 CHANNEL COCHLEAR CHANGES
IMPLANT ENGLEWOOD, CO
80112
P840039/S030 SINGLE-PIECE STORZ OPHTHALMICS, ADDITION OF D & C
02/07/96 ULTRAVIOLET- INC. GREEN NO. 6 DYE TO
ABSORBING CLEARWATER, FL THE HAPTICS; NEW
POSTERIOR 34619 TRADE NAME BLUE
CHAMBER VISTA
INTRAOCULAR
LENSES (IOLS)
P840039/S031 ULTRAVIOLET- STORZ OPHTHALMICS, ADDITIONAL/ALTERNATIVE
02/07/96 ABSORBING INC. VENDOR FOR
POSTERIOR CLEARWATER, FL POLYMETHYMETHACRYLATE
CHAMBER 34619 (PMMA) WITH INTRAOCULAR
ULTRAVIOLET- LENSES (IOLS)
ABSORBER CYASORB 24
AND A NEW FORMULATION
OF THE PMMA
P840060/S022 POSTERIOR CHAMBER ALCON LABORATORIES, TIER A MODELS
02/20/96 INTRAOCULAR LENSES
(IOLS) FORT WORTH, TX
76134-2099
P840066/S029 CONSEPT CLEANING ALLERGAN, INC. UNPRESERVED
02/29/96 AND DISINFECTING FORMULATION OF
SYSTEM IRVINE, CA CONSEPT-2
92713 NEUTRALIZING AND
RINSING SOLUTION TO
BE PACKAGED IN A
NON-AEROSOL
CONTAINER
P850088/S034 OXYSEPT 1/ ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 ULTRACARE STERILIZATION SITE
DISINFECTING IRVINE, CA AND THE USE OF 100%
SOLUTION 92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P860019/S109 SCIMED SCIMED LIFE SYSTEMS, USE OF AN EPOXY
02/05/96 PERCUTANEOUS INC. ADHESIVE IN THE
TRANSLUMINAL MAPLE GROVE, MN MANIFOLD OF THE BANDIT
CORONARY 55311-1566 POC BANDIT, AND THE
ANGIOPLASTY 15 MM NC BANDIT
CATHETERS PERCUTANEOUS
TRANSLUMINAL CORONARY
ANGIOPLASTY CATHETERS
P860019/S110 SCIMED SCIMED LIFE SYSTEMS, APPROVAL FOR:1)10 AND
02/26/96 PERCUTANEOUS INC. 20 MM BALLOON
TRANSLUMINAL MAPLE GROVE, MN LENGTHS; 2) 2.0 AND
CORONARY 55311-1566 2.25 DIAMETER
ANGIOPLASTY BALLOONS IN THE 20 MM
CATHETERS LENGTH; AND 3) THE
USE OF AN EPOXY
ADHESIVE
P870025/S004 MODEL 146 FETAL COROMETRICS MEDICAL CHANGES IN THE
02/01/96 ACOUSTIC SYSTEMS, INC. QUALITY CONTROL
STIMULATOR WALLINGFORD, CT AND MANUFACTURING
06492-0333 PRACTICES FOR THE
TRANSDUCER
P870026/S007 RESOLVE/GP ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 DAILY CLEANER STERILIZATION SITE
IRVINE, CA AND THE USE OF 100%
92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P870037/S008 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 WETTING AND STERILIZATION SITE
SOAKING IRVINE, CA AND THE USE OF 100%
SOLUTION 92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P880047/S004 INTERCEED JOHNSON & JOHNSON LABELING CHANGES
02/08/96 ABSORBABLE MEDICAL, INC.
ADHESION BARRIER ARLINGTON, TX
76004-9962
P880072/S036 MODIFIED J-LOOP MEDICAL DEVELOPMENT ALTERNATE CONTRACT
02/12/96 POSTERIOR CHAMBER RESEARCH, INC. STERILIZER, MEDICAL
INTRAOCULAR ST. PETERSBURG, FL MANUFACTURING, CORP.,
LENSES (IOLS) 33716 ERIE, PA 16510, AND
CONVERSION FROM 12/88
ETHYLENE OXIDE (ETO/
FREON TO 100% ETO
STERILIZATION
P890027/S025 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS
02/13/96 CHANNEL COCHLEAR CHANGES
IMPLANT ENGLEWOOD, CO
80112
P890061/S011 VENTAK P MODEL GUIDANT CORPORATION REPLACING THE CURRENT
02/20/96 1600 CONNECTOR TOP MATERIAL
ST. PAUL, MN FOR THE ABOVE AICD
55112-5798 MODEL, PELLETHANE 2363-
75D POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P900030/S004 CONTIGEN BARD COLLAGEN CORP. APPROVAL FOR A
02/01/96 COLLAGEN IMPLANT MANUFACTURING CHANGE
PALO ALTO, CA
94303
P900039/S009 COLLAGRAFT BONE COLLAGEN CORP. APPROVAL FOR A
02/01/96 GRAFT MATRIX MANUFACTURING CHANGE
PALO ALTO, CA
94303
P900047/S004 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 REWETTING DROPS STERILIZATION SITE
SANTA ISABEL, PR AND USE OF 100%
00757 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P910075/S006 COMPLETE ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 BRAND MULTI- STERILIZATION SITE
PURPOSE IRVINE, CA AND USE OF 100%
SOLUTION 92713-9534 ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND
CAPS
P910077/S010 VENTAK PRX GUIDANT CORP. REPLACING THE CURRENT
02/05/96 MODEL 1705, CONNECTOR TOP MATERIAL
PRX II MODEL ST. PAUL, MN FOR THE ABOVE AICD
1715, AND PRX 55112-5798 MODEL, PELLETHANE 2363-
III MODELS 1720/ 75D POLYURETHANE, WITH
1725 TECOTHANE TT1075D-M
POLYURETHANE
P910077/S011 VENTAK PRX II/ CPI/GUIDANT, APPROVAL FOR THE USE
02/05/96 III AICD CORP. OF MODEL 2872
SYSTEMS ST. PAUL, MN SOFTWARE APPLICATION,
551125798 REV. 4.1 AND MODEL
2909 MULTIPLE
APPLICATION UTILITY
(MAU) WITH THE VENTAK
PRX II/III
P920021/S001 OPUS CEA TEST BEHRING DIAGNOSTICS, APPROVAL TO ADD THE
02/23/96 SYSTEM INC. CEA TEST SYSTEM TO
WESTWOOD, MA THE OPUS PLUS AND
02090 OPUS MAGNUM
ANALYZERS. THE SAME
TEST SYSTEM IS USED
ON ALL THREE
INSTRUMENTS
P920047/S003 EP TECHNOLOGIES EP TECHNOLOGIES, INC. ADDITION OF
02/05/9 EPT-100 CARDIAC ALTERNATIVE CATHETER
ABLATION SYSTEM SUNNYVALE, CA CONFIGURATIONS
94086
P930029/S006 ATAKR RFCA MEDTRONIC APPROVAL OF THE
02/22/96 SYSTEM CARDIORHYTHM ABLATION TRACKR
SAN JOSE, CA SOFTWARE FOR USE WITH
95134-1806 THE ATAKR RF CATHETER
ABLATION GENERATOR
SYSTEM
P930035/S004 VENTAK P2 MODEL GUIDANT CORPORATION REPLACING THE CURRENT
02/20/96 1625 AND P3 CONNECTOR TOP MATERIAL
MODELS 1630/1635 ST. PAUL, MN FOR THE ABOVE AICD 55112-5798 MODEL, PELLETHANE 2363- 75D POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P940031/S001 VIGOR(TM) DR CARDIAC PACEMAKERS, REPLACING THE CURRENT
02/20/96 PACEMAKER SYSTEM INC. CONNECTOR TOP MATERIAL
ST PAUL, MN FOR THE ABOVE AICD 55112 MODEL, PELLETHANE 2363-
75D POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P940031/S002 VIGOR DR CARDIAC ADDING AN ALTERNATE
02/26/96 MODEL 1230 PACEMAKERS (CPI) LOWER PROFILE CONNECTOR
PACEMAKER ST. PAUL, MN TOP FOR THE VIGOR DR
55112-5798 MODEL 1230 PACEMAKERS
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