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Medical Devices
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June 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for June 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
P910074 CONTACLAIR EUREXPAN INDICATED FOR
06/20/96 MULTI-PURPOSE LABORATORIES CLEANING, RINSING,
SOLUTION CELLETTES, FR DISINFECTING AND
STORING DAILY AND
EXTENDED WEAR CLEAR
AND TINTED SOFT
CONTACT LENSES
PMA SUPPLEMENTAL APPROVALS
P820018/S069 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER MODEL SYSTEMS NETWORK PROGRAMMER
9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3
P830071/S006 ALCON WETTING, ALCON LABORATORIES, ALTERNATE FORMULATION
06/04/96 SOAKING, INC. DEVICE INDICATED FOR
CONDITIONING, AND FORT WORTH, TX THE DISINFECTION AND
DISINFECTING 76134-2099 CONDITIONING AFTER
SOLUTION ID 84392 CLEANING AND RINSING
OF CLEAR AND TINTED
DAILY AND EXTENDED
WEAR
P840024/S063 NUCLEUS 22 COCHLEAR REVISIONS TO THE
06/20/96 CHANNEL COCHLEAR CORPORATION WARNINGS SECTION IN
IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT
80112 AND PATIENT
IDENTIFICATION CARD
P840024/S064 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI
06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S
IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT(IC)
80112 (IC2401) THE NEW IC
IS DESIGNED TO
OPTIMIZE ELECTROSTATIC
DISCHARGE PROTECTION
OF THE MINI COCHLEAR
IMPLANT, MODEL C122M
P840039/S049 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34 D)
TO (-18.0 D) - (+45 D)
PMA Supplement Approvals
P840064/S017 VISCOAT ALCON LABORATORIES, 1) ALTERNATE
06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS;
SOLUTION FORT WORTH, TX USING 100% ETHYLENE
76134-2099 OXIDE 2) SHELF LIFE OF
24 MONTHS FOR VISCOAT
AND 36 MONTHS FOR
PROVISC; AND 3)
ALTERNATE PACKAGING
FOR PROVISC
P840068/S019 VISTA DDD MODEL CPI/GUIDANT TWO NEW MODELS OF
06/19/96 942, 944, AND CORPORATION VISTA DDD PULSE
SOFTWARE MODULE ST. PAUL, MN GENERATORS AND A
MODEL 2052 55112-5798 SOFTWARE MODULE
P860002/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34 D)
TO (-18.0 D) - (+45 D)
P860019/S108 SCIMED WAVE SCIMED LIFE SYSTEMS, INTENDED FOR THE
06/10/96 PERCUTANEOUS INC. BALLOON DILATATION
TRANSLUMINAL MAPLE GROVE, MN OF THE STENOTIC
CORONARY 55311-1566 PORTION OF A CORONARY
ANGIOPLASTY ARTERY OR BYPASS GRAFT
(PTCA) STENOSIS FOR THE
PERFUSION CATHETER PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P870018/S014 LITHOSTAR SIEMENS MEDICAL 1)MODIFICATIONS TO A
06/06/96 SHOCK WAVE SYSTEMS, INC. PROGRAMMABLE READ
SYSTEM C ISELIN, NJ ONLY MEMORY INTEGRATED
08830 CIRCUIT; AND 2)MINOR
LABELING CHANGES
P870018/S015 MOBILE SIEMENS MEDICAL APPROVAL FOR A MOBILE
06/05/96 LITHOSTAR SYSTEM, INC. VERSION OF THE
WITH SHOCK ISELIN, NJ LITHOSTAR SHOCK WAVE
WAVE SYSTEM C 08830 SYSTEM C
(SWSC)
P870018/S016 LITHOSTAR SIEMENS MEDICAL MODIFICATION OF
06/21/96 LITHOTRIPTER SYSTEMS, INC. USER'S MANUAL
ISELIN, NJ
08830
P870076/S004 FALOPE-RING CIRCON-CABOT MEDICAL ALTERNATE
06/14/96 BAND CORPORATION MANUFACTURING SITE
CONTRACEPTIVE LANGHORNE, PA
TUBAL OCCLUSION 19047
SYSTEM
P880003/S054 CORDIS PERCUTANEOUS CORDIS CORPORATION ALTERNATE
06/13/96 TRANSLUMINAL STERILIZATION SITE
CORONARY MIAMI, FL (ISOMEDIX) IN
ANGIOPLASTY 33102-5700 NORTHBOROUGH,
DILATATION MASSACHUSETTS
CATHETERS
P880003/S059 CORDIS PERCUTANEOUS CORDIS CORPORATION MODIFIED BALLOON
06/05/96 TRANSLUMINAL FOLDING MACHINE
CORONARY MIAMI LAKES, FL
ANGIOPLASTY 33014-5700
(PTCA) DILATATION
CATHETERS
P880027/S038 ASUKA AND ASUKA SCHNEIDER (USA), INC. INDICATED FOR BALLOON
06/12/96 LONGY OVER-THE- DILATATION OF THE
WIRE PERCUTANEOUS PLYMOUTH, MN STENOTIC PORTION OF
TRANSLUMINAL 55442 A CORONARY ARTERY OR
CORONARY BYPASS GRAFT STENOSIS
ANGIOPLASTY (PTCA) FOR THE PURPOSE OF
CATHETERS IMPROVING MYOCARDIAL
PERFUSION
P880038/S031 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER MODEL SYSTEMS NETWORK PROGRAMMER
9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3
P880090/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 ANTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE ANTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34D) TO
(-4.5 D) - (+45D)
P890001/S011 LEOCOR PERCUTANEOUS LEOCOR, INC. CHANGE IN THE
06/13/96 ANGIOPLASTY INSTRUCTIONS FOR USE,
CATHETER (PTCA), HOUSTON, TX ADDITION OF A PUMP
MODEL 5S, LEOCOR 77058-2536 HEAD WITH LONGER
CORFLO MODEL 7.5PT TUBING, CHANGE IN THE
COATED PTCA, AND CLEANING PROCESS, AND
CORFLO ADDITION OF STOPCOCKS
HEMOPERFUSION PUMP ON THE PUMPS
P890001/S014 LEOCOR PERCUTANEOUS LEOCOR, INC. REVISED LABELING
06/13/96 TRANSLUMINAL
CORONARY HOUSTON, TX
ANGIOPLASTY 77058-2536
CATHETER AND LEOCOR
PTCA CATHETER MODEL
PICO-ST (COATED)
P890001/S015 LEOCOR PICO LEOCOR, INC. EXTENSION OF THE
06/07/96 RUNNER PTCA LEOCOR PICO RUNNER
CATHETER HOUSTON, TX PTCA CATHETER LINE TO
77058-2536 INCLUDE A 4.0MM
BALLOON DIAMETER
P890027/S032 NUCLEUS 22 COCHLEAR REVISIONS TO THE
06/13/96 CHANNEL COCHLEAR CORPORATION WARNING SECTION IN
IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT
80112 AND PATIENT
IDENTIFICATION CARD
P890027/S033 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI
06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S
IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT
80112 (IC2401)
P890047/S010 PROVISC ALCON LABORATORIES, 1) ALTERNATE
06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS
MATERIAL FORT WORTH, TX USING 100% ETHYLENE
76134-2099 OXIDE 2) SHELF LIFE
OF 24 MONTHS FOR
VISCOAT AND 36 MONTHS
FOR PROVISC 3)
ALTERNATE PACKAGING
FOR PROVISC
P890055/S001 M3000 CONSTANT ARROW ADDITION OF THE
06/27/96 FLOW IMPLANTABLE INTERNATIONAL "MODEL 3000
PUMP WITH BOLUS WALPOLE, MA MEDICATION
SAFETY VALVE 02081 CALCULATOR" TO THE
LABELING
P900047/S005 CLARIS ALLERGAN OPTICAL 1) DUPLICATE WET-N-
06/20/96 REWETTING DROPS SOAK REWETTING DROPS
IRVINE, CA UNDER THE TRADE NAME
91713-9534 CLARIS REWETTING
DROPS 2) ADDITIONAL
STATEMENT TO THE
DIRECTIONS SECTION
P900070/S006 META DDDR TELECTRONICS PACING APPROVAL FOR THE
06/28/96 PACEMAKER PULSE SYSTEMS, INC. META DDDR PACEMAKER
GENERATORS MODELS ENGLEWOOD, CO PULSE GENERATORS
1256, 1256D, & 80112 MODELS 1256, 1256D,
1256B (FORMERLY AND 1256B (FORMERLY
1256R) 1256R)
P900070/S011 META DDDR PACING TELECTRONICS PACING MODIFICATION IN THE
06/21/96 SYSTEM SYSTEMS, INC. PULSE GENERATOR
ENGLEWOOD, CO DESIGN IN THE
80112 TELEMETRY COIL
CONNECTION
P900070/S012 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER MODEL SYSTEMS, INC. NETWORK PROGRAMMER
9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3.
P910023/S014 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR THE
06/11/96 THERAPY VENTRITEX EXTERNAL
DEFIBRILLATOR SUNNYVALE, CA STIMULATOR ADAPTER
SYSTEM 94086-6527 (VESA) AND THE
VENTRITEX HIGH
VOLTAGE Y-ADAPTER
P910023/S018 CADET TIERED VENTRITEX, INC. APPROVAL FOR TWO
06/11/96 THERAPY HEADER CONFIGURATIONS
DEFIBRILLATOR SUNNYVALE, CA (MODELS V-105/V115
SYSTEM 94086-6527 AND MODELS
V-105B/V-115B, AS
PART OF THE CADET
TIERED THERAPY
DEFIBRILLATOR SYSTEM
P920051/S003 STORZ MODULITH KARL STORZ NEW MODEL
06/21/96 LITHOTRIPTER, LITHOTRIPSY-AMERICA THE DEVICE, AS
MODEL SLX KENNESAW, GA MODIFIED, WILL BE
30144 MARKETED UNDER THE
TRADE NAME THE STORZ
MODULITH LITHOTRIPTER
MODEL SLX
P930029/S005 ADDITION OF RF MEDTRONIC ADDITION OF THE RF
06/11/96 PERFORMR CARDIOPULMONARY DIV. PERFORMR SERIES OF
SAN JOSE, CA CARDIAC ABLATION
95134-1806 CATHETERS FOR THE
ATAKR RFCA SYSTEM
P940034/S002 GEN-PROBE GEN-PROBE INC. MODIFIED PACKAGE
06/05/96 AMPLIFIED INSERT TO INCLUDE
MYCOBACTERIUM SAN DIEGO, CA MORE DETAILS ON
TUBERCULOSIS 92121-1589 ADEQUATE VORTEXING
DIRECT (MTD) TEST
P950014/S001 PROSTATRON EDAP TECHNOMED APPROVAL TO SUPPLY
06/20/96 GROUP (USA), INC. THE PROSTATRON
CAMBRIDGE, MA TREATMENT CATHETER
02139 (I.E., THE
PROSTAPROBE) IN
STERILE FORM
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