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PMA Final Decisions Rendered for March 1997 |
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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.
APPLICATION DEVICE TRADE COMPANY NAME DEVICE DESCRIPTION/
NUMBER NAME CITY, STATE, & ZIP INDICATIONS
P940002 NATURAL-KNEE7 SULZER ORTHOPEDICS7 APPROVAL FOR THE
03/21/97 AND NATURAL INC. NATURAL-KNEE7 AND
KNEE7 II WITH AUSTIN, TX NATURAL KNEE7 II
CSTIJ 78717 WITH CSTIJ. THESE
DEVICES ARE INDICATED
FOR UNCEMENTED USE IN
SKELETALLY MATURE
INDIVIDUALS WITH
INTACT MEDIAL AND
LATERAL COLLATERAL
LIGAMENTS UNDERGOING
PRIMARY SURGERY FOR
REHABILITATING KNEES
DAMAGED AS A RESULT
OF NONINFLAMMATORY
DEGENERATIVE JOINT
DISEASE (NIDJD) OR
INFLAMMATORY JOINT
DISEASE (IJD).
P950029 CHORUS RM MODEL ELA MEDICAL, INC. APPROVAL FOR CHORUS
03/10/97 7034 DDDR RM MODEL 7034 DDDR
PACEMAKER SYSTEM PLYMOUTH, MN PACEMAKER SYSTEM
AND OPUS RM MODEL 55441 AND OPUS RM MODEL
4534 SSIR PACEMAKER 4534 SSIR PACEMAKER
SYSTEM SYSTEM WHICH INCLUDES
AN IBM COMPATIBLE
MICROCOMPUTER WHICH
HAS BEEN CONFIGURED
AND FURNISHED BY ELA
MEDICAL, INC. WITH
CSO 2.46 PROGRAMMING
SOFTWARE AND IS
CONNECTED TO A CPR1
PROGRAMMING HEAD.
THESE DEVICES ARE
INDICATED FOR: RATE
ADAPTIVE PACING IN
PATIENTS WHO MAY
BENEFIT FROM
INCREASED PACING
RATES CONCURRENT WITH
INCREASES IN MINUTE
VENTILATION; AND THE
GENERALLY ACCEPTED
PATIENT CONDITIONS
WARRANTING CHRONIC
CARDIAC PACING.
P960007 DERMAGRAFT ADVANCED TISSUE APPROVAL FOR THE
03/18/97 TEMPORARY SCIENCES DERMAGRAFT-TCJ.
COVERING, LAJOLLA, CA THE DEVICE IS
DERMAGRAFT-TCJ 92037-1005 INDICATED FOR USE AS
A TEMPORARY WOUND
COVERING FOR
SURGICALLY EXCISED
FULL-THICKNESS AND
DEEP PARTIAL-
THICKNESS
THERMAL BURN WOUNDS
IN PATIENTS WHO
REQUIRE SUCH A
COVERING PRIOR TO
AUTOGRAFT PLACEMENT.
P960044 NEEDLE-EASEJ MILLENIUM MEDICAL APPROVAL FOR THE
03/06/97 2501 SUPPLY, INC. NEEDLE-EASEJ 2501.
WASHINGTON, D.C. THIS DEVICE IS A
20004 SHARPS NEEDLE
DESTRUCTION DEVICE
THAT IS INTENDED FOR
HOME USE BY DIABETICS
TO REDUCE THE
INCIDENCE OF
NEEDLESTICKS BY THE
INCINERATION OF 28-30
GAUGE NEEDLES, 29 AND
30 GAUGE DIABETIC
"PEN TIPS" AND 23-26
GAUGE DIABETIC
LANCETS.
N50510/S074 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR
03/17/97 "GENERAL INC. LEVOFLOXACIN TO BE
SUSCEPTIBILITY HAZELWOOD, MO INCLUDED ON THE GRAM
CARD" 63042-2395 POSITIVE
SUSCEPTIBILITY CARD
IN THREE
CONCENTRATIONS
(EQUIVALENT TO 2, 4
AND 8UG/ML).
N50510/S076 VITEK SYSTEMS BIOMERIEUX VITEK, APPROVAL FOR
03/27/97 "GENERAL INC. LEVOFLOXACIN TO BE
SUSCEPTIBILITY HAZELWOOD, MO INCLUDED ON THE GRAM
CARD" 63042-2395 NEGATIVE
SUSCEPTIBILITY CARD
IN THREE
CONCENTRATIONS
(EQUIVALENT TO 1, 4
AND 8 UG/ML).
P790017/S061 USCI7 PROCROSSJ C.R. BARD, INC. APPROVAL FOR
03/03/97 OVER THE WIRE ADDITIONAL QUARTER
BALLOON DILATATION BILLERICA, MA MILLIMETER DIAMETER
CATHETER WITH 01821 SIZE MODELS OF THE
RELYJ BALLOON PROCROSSJ CATHETER
MATERIAL AND LINE. THE DEVICE, AS
HYDRO/PEL7 MODIFIED, WILL BE
COATING MARKETED UNDER THE
TRADE NAME USCI7
PROCROSSJ
OVER-THE-WIRE
DILATATION CATHETER
WITH RELYJ BALLOON
MATERIAL AND
HYDRO/PEL7 COATING
AND IS INDICATED FOR
BALLOON DILATATION OF
THE STENOTIC PORTION
OF A CORONARY ARTERY
OR BYPASS GRAFT
STENOSIS FOR THE
PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION.
P790018/S029 MEDTRONIC7 HALL MEDTRONIC, INC. APPROVAL FOR A
03/17/97 PROSTHETIC HEART MANUFACTURING SITE
VALVE MINNEAPOLIS, MN LOCATED AT MEDTRONIC
55440 INC., SPRING LAKE
PARK, MN.
P790019/S008 ABBOTT IMX7 ABBOTT LABORATORIES APPROVAL FOR A CHANGE
03/27/97 HAVAB7-M IN THE REFERENCE
ABBOTT PARK, IL PANEL, TO REMOVE THE
60064 IGM ANTI-HBC POSITIVE
PLASMA AND THE
RHEUMATOID FACTOR
POSITIVE PLASMA MIXED
WITH HIGH TITER
ANTI-HAV IGG POSITIVE
PLASMA.
P820003/S072 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR THE
03/27/97 5388 TEMPORARY MEDTRONIC MODEL 5388
PACEMAKER MINNEAPOLIS, MN TEMPORARY PACEMAKER.
55432
P820031/S014 BAUSCH & LOMB7 GLOBAL VISION CARE APPROVAL FOR REDUCING
03/10/97 RENU7 LENS BAUSCH & LOMB, INC. THE FILL VOLUME FOR
REWETTING DROPS ROCHESTER, NY RENU7 LENS REWETTING
14692 DROPS FROM THE
CURRENTLY APPROVED
5 ML TO 3 ML IN THE SAME 7.5 ML
BOTTLE.
P830034/S031 OPTI-FREE7 ALCON LABORATORIES APPROVAL FOR REDUCING
03/26/97 REWETTING DROPS INC. THE FILL VOLUME OF
FORT WORTH, TX OPTI-FREE7
76134-2099 REWETTING DROPS FROM
THE CURRENTLY
APPROVED 5 ML TO 3 ML
IN THE SAME OPAQUE
LOW DENSITY
POLYETHYLENE (LDPE)
BOTTLE.
P830034/S033 OPTI-FREE7 ALCON LABORATORIES APPROVAL FOR A
03/19/97 RINSING, INC. MODIFICATION IN THE
DISINFECTING, AND FORT WORTH, TX PACKAGE INSERT TO
STORAGE SOLUTION 76134-2099 INCLUDE ADDITION OF
OPTI-FREE7 THE FOLLOWING
EXPRESSJ MULTI- STATEMENT IN THE
PURPOSE SOLUTION DIRECTIONS SECTIONS:
"YOU MAY STORE YOUR
LENSES IN THE
UNOPENED CASE UNTIL
READY TO WEAR, UP TO
A MAXIMUM OF THIRTY
DAYS. IF YOUR LENSES
ARE STORED FOR LONGER
PERIODS OF TIME, THEY
MUST BE CLEANED AND
DISINFECTED WITH
FRESH SOLUTION EVERY
THIRTY DAYS AND PRIOR
TO WEAR."
P830039/S006 OMNISCEINCE7 MEDICAL, INC. APPROVAL FOR AN
03/26/97 CARDIAC VALVE EXTENSION OF SHELF
PROSTHESIS INVER GROVE HEIGHTS, LIFE FROM THREE YEARS
55007 TO TEN YEARS AFTER
THE INITIAL
STERILIZATION OF THE
OMNISCIENCE VALVE.
P830071/S009 OPTI-SOAK7 ALCON LABORATORIES APPROVAL FOR A
03/19/97 CONDITIONING INC. MODIFICATION IN THE
SOLUTION FORT WORTH, TX PACKAGE INSERT TO
ALCON WETTING, 76134-2099 INCLUDE ADDITION OF
SOAKING, THE FOLLOWING
CONDITIONING, AND STATEMENT IN THE
DISINFECTING DIRECTIONS SECTIONS:
SOLUTION ID 84392 "YOU MAY STORE YOUR
LENSES IN THE
UNOPENED CASE UNTIL
READY TO WEAR, UP TO
A MAXIMUM OF THIRTY
DAYS. IF YOUR LENSES
ARE STORED FOR LONGER
PERIODS OF TIME, THEY
MUST BE CLEANED AND
DISINFECTED WITH
FRESH SOLUTION EVERY
THIRTY DAYS AND PRIOR
TO WEAR."
P840068/S031 VIGOR7 MODEL 2880 CARDIAC PACEMAKERS APPROVAL FOR THE
03/25/97 SOFTWARE (CPI) GUIDANT CORP. VIGOR MODEL 2880
APPLICATION ST. PAUL, MN SOFTWARE APPLICATION
VERSION 3.0 55112-5798 VERSION 3.0, TO BE
USED WITH MODEL 2950
OR MODEL 2901
PROGRAMMER/RECORDER/
MONITOR DEVICES.
P850077/S022 SUNSOFT SUNSOFT APPROVAL FOR AN
03/10/97 (METHAFILCON A) ALTERNATE MOLDED LENS
SOFT(HYDROPHILIC) ALBUQUERQUE, NM MANUFACTURING
CONTACT LENS 87109 PROCESS. THE DEVICE,
(CLEAR AND TINTED) AS MODIFIED, WILL BE
MARKETED UNDER THE
TRADE NAME SUNSOFT
MULTIPLESJ.
P850089/S035 MEDTRONIC CAPSURE7 CARDIAC PACING BUSINESS APPROVAL FOR THE USE
03/07/97 SP MODEL 5024M/ MEDTRONIC, INC. OF NUSIL MED-4719 AS
5524M PACING MINNEAPOLIS, MN AN ALTERNATE SILICONE
LEADS 55432-3576 INSULATOR FOR
MDX4-4516.
P860003/S028 THERAKOS UVAR7 THERAKOS, INC., APPROVAL FOR THE USE
03/25/97 PHOTOPHORESIS OF EXTERNAL
SYSTEM EXTON, PA BIOLOGICAL INDICATORS
19341 TO MONITOR THE
STERILIZATION CYCLES
FOR THE PHOTOPHERESIS
TPS101 BLOOD TUBING
SET, TPS102
PHOTOCEPTOR7, AND A
COMMERCIALLY
AVAILABLE BLOOD
CENTRIFUGE BOWL.
P870036/S041 MEDTRONIC7 MEDTRONIC APPROVAL FOR A
03/07/97 EVERGREENJ INTERVENTIONAL MODIFIED BONDING
CORONARY BALLOON SAN DIEGO, CA PROCESS FOR THE
DILATATION 92121-2256 RADIOPAQUE MARKER
CATHETERS BANDS.
P870076/S006 FALOPE-RING BAND CIRCON CORP. APPROVAL FOR A
03/21/97 CONTRACEPTIVE MANUFACTURING SITE
TUBAL OCCLUSION SANTA BARBARA, CA LOCATED AT
SYSTEM 93117-3019 CIRCON-SURGITEK, 3037
MT. PLEASANT ST.,
RACINE, WI.
P880031/S022 SLM-2 ALLERGAN MEDICAL REVISED LABELING.
03/24/97 ULTRAVIOLET- OPTICS, INC.
ABSORBING IRVINE, CA
POSTERIOR 92713-9534
CHAMBER
INTRAOCULAR
LENSES (IOLS)
P880072/S045 INTRAOCULAR MEDICAL DEVELOPMENT APPROVAL FOR AN
03/13/97 LENSES RESEARCH, INC. ALTERNATE
ST. PETERSBURG, FL STERILIZATION SITE
33716 LOCATED AT TRI-STATE,
HOSPITAL SUPPLY
CORP., SALISBURY,
N.C. 28147.
P880081/S022 MODEL SI-11NB UV ALLERGAN MEDICAL APPROVAL FOR REVISING
03/24/97 ABSORBING OPTICS THE LABELING.
SILICONE IRVINE, CA
POSTERIOR IOL 92713
P880086/S039 TRILOGY SR+ MODEL PACESETTER, INC. APPROVAL FOR THE
03/12/97 2260L AND 2264L ST.JUDE MEDICAL CO. TRILOGY SR+ MODEL
CARDIAC PULSE SYLMAR, CA 2260L AND 2264L
GENERATORS WITH 91392-9221 CARDIAC PULSE
THE MODEL 3023 GENERATORS WITH THE
PDX FUNCTION MODEL 3023 PDX
PACK FUNCTION PACK.
P900009/S003 SONIC ACCELERATED ADVANCED BIORESEARCH APPROVAL FOR THE
03/27/97 FRACTURE HEALING ASSOCIATES SONIC ACCELERATED
SYSTEM (SAFHS) PISCATAWAY, NJ FRACTURE HEALING
MODEL 2000J 08855 SYSTEM (SAFHS) MODEL
2000J.
P900043/S005 PALMAZ-SCHATZJ CORDIS CORP. APPROVAL FOR CHANGES
03/13/97 BALLOON IN THE BALLOON
EXPANDABLE STENT WARREN, NJ FOLDING AND STENT
07059 CRIMPING
MANUFACTURING PROCESS
AND THE ADDITION OF A
NEW STENT RETENTION
TEST.
P900060/S012 CARBOMEDICS7 CARBOMEDICS, INC. APPROVAL FOR A VALVED
03/07/97 PROSTHETIC HEART GRAFT VERSION OF THE
VALVE(CPHV) AUSTIN, TX CARBOMEDICS7
CARBOMEDICS7 78752-1793 PROSTHETIC HEART
CARBO-SEALJ VALVE (CPHV). THE
ASCENDING AORTIC DEVICE, AS MODIFIED,
PROSTHESIS (AAP) WILL BE MARKETED
UNDER THE TRADE NAME
CARBOMEDICS7
CARBO-SEALJ
ASCENDING AORTIC
PROSTHESIS (AAP) AND
IS INDICATED FOR USE
IN OPEN HEART SURGERY
FOR SIMULTANEOUS
REPLACEMENT OF THE
ASCENDING AORTA AND
THE AORTIC VALVE IN
CASES OF ANEURYSM,
DISSECTION, OR OTHER
DISEASE CONDITIONS OF
THE AORTA COMBINED
WITH DISEASE OR
DEGENERATION OF THE
AORTIC VALVE. THE
DEVICE IS AVAILABLE
IN THE SIZES OF 21,
23, 25, 27, 29, 31,
AND 33 MM.
P900061/S029 JEWEL7 MODELS MEDTRONIC, INC. APPROVAL FOR JEWEL7
03/07/97 7219B/D/E, 7202 MODELS 7219 B/D/E,
D/E, 7220 B/D/E, MINNEAPOLIS, MN 7202 D/E, 7220 B/D/E,
7221 B/CX/D/E 55432-3576 7221 B/CX/D/E
MICROJEWELJ, AND MICROJEWELJ, AND
7223 MICRO JEWEL 7223 MICRO JEWEL
IIJ WITH ENDOTAK7 IIJ WITH
DSP LEAD MODELS ENDOTAK7 DSP LEAD
0092, 0093, 0094, MODELS 0092, 0093,
0096, 0097, 0123, 0094, 0096, 0097,
AND 0125 AND THE 0123, AND 0125 AND
MODEL 6836 THE MODEL 6836 Y
Y CONNECTOR CONNECTOR.
P900061/S030 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR USE OF
03/06/97 7221 MICRO THE WILSON GREATBACH
JEWEL7 MINNEAPOLIS, MN LIMITED MODEL 9517
55432-3576 BATTERY AS AN
ALTERNATE POWER
SOURCE FOR THE MODEL
7221 MICRO JEWEL7.
P900061/S031 MEDTRONIC7 MEDTRONIC, INC. APPROVAL FOR THE
03/13/97 MODEL 6925 MODEL 6925 UPSIZING
UPSIZING SLEEVE MINNEAPOLIS, MN SLEEVE WHICH WILL
55432-3576 ALLOW A 5.0 MM LEAD
CONNECTOR TO FIT INTO
A 6.5 MM CONNECTOR
PORT OF A MEDTRONIC
IMPLANTABLE
DEFIBRILLATOR.
P910023/S015 VENTRITEX7 VENTRITEX, INC. APPROVAL FOR
03/03/97 HOUSECALLJ VENTRITEX7
SYSTEM SUNNYVALE, CA HOUSECALLJ SYSTEM
94086-6527 WITH TRANSMITTER
MODEL TR 2400
(SOFTWARE VERSION
1.1) AND RECEIVER
MODEL RE 2400
(SOFTWARE VERSION
1.0).
P910023/S025 CADENCE7 TIERED VENTRITEX, INC. APPROVAL FOR USE OF
03/03/97 THERAPY PROGRAMMER SOFTWARE
DEFIBRILLATOR SUNNYVALE, CA VERSION 4.1.5G.
SYSTEM 94086-6527
P910064/S013 REALITYJ THE FEMALE HEALTH CO. APPROVAL FOR 1)A
03/07/97 FEMALE CONDOM MODIFICATION OF THE
CHICAGO, IL SHELF LIFE PROTOCOL
60611 TO REVISE THE FILM
STRENGTH
SPECIFICATION FROM 35
MPA TO 25.8 MPA; 2) A
MODIFICATION ON THE
SHELF LIFE PROTOCOL
TO ASSESS THE FINAL
RESULTS OF EACH LOT
ON AN INDIVIDUAL
BASIS, INSTEAD OF AS
AN AVERAGE OF A
SERIES; AND 3) AN
EXTENSION OF THE
PRODUCT SHELF LIFE
FROM 36 MONTHS TO 60
MONTHS FOR PRODUCT
PRODUCT MANUFACTURED
AT BOTH THE WISCONSIN
PHARMACAL AND THE
CHARTEX MANUFACTURING
PLANTS.
P910067/S002 EXCIMED UV 200LA, SUMMIT TECHNOLOGY, APPROVAL FOR A NEW
03/12/97 SVS APEX, AND INC. LASER CALIBRATION
SVS APEX PLUS WALTHAM, MA MEDIUM AND PROCEDURE.
EXCIMER LASER 02154
SYSTEMS FOR
PHOTOTHERAPEUTIC
KERATECTOMY (PTK)
P920034/S001 TRIPTER-X1 SERIES MEDIREX, INC. APPROVAL FOR LABELING
03/26/97 LITHOTRIPTERS CHANGES DESCRIBING
WELLESLEY HILLS, MA THE TRANSPORTABILITY
02181 OF THE DEVICE.
P920047/S006 EPT-1000 CARDIAC EP TECHNOLOGIES, INC. APPROVAL FOR AN
03/12/97 ABLATION SYSTEM ALTERNATIVE HANDLE
SUNNYVALE, CA CONFIGURATION FOR
94086 THEIR EXISTING
CARDIAC ABLATION
CATHETERS.
P920051/S006 STORZ KARL STORZ APPROVAL FOR THE OEC
03/27/97 TRANSPORTABLE ENDOSCOPY-AMERICA, INC. SERIES 9600 MOBILE
MODULITH7 SLX CULVER CITY, CA IMAGING UNIT AND A
LITHOTRIPTER 90230-7600 PORTABLE COLLISION
PROTECTOR TO BE USED
WITH A TRANSPORTABLE
VERSION OF YOUR SLX
LITHOTRIPTER. THE
DEVICE, AS MODIFIED,
WILL BE MARKETED
UNDER THE TRADE NAME
TRANSPORTABLE
MODULITH7 SLX
LITHOTRIPTER AND IS
INDICATED FOR USE IN
THE NONINVASIVE
FRAGMENTATION OF
URINARY CALCULI IN
THE KIDNEY AND UPPER
URETER.
P930034/S007 SVS APEX APEX SUMMIT TECHNOLOGY, APPROVAL FOR A NEW
03/12/97 AND SVS APEX INC. LASER CALIBRATION
PLUS EXCIMER WALTHAM, MA MEDIUM AND PROCEDURE.
LASER SYSTEM 02154
FOR
PHOTOREFRACTIVE
KERATECTOMY (PRK)
P940031/S008 VIGOR7 MODEL 2880 CARDIAC PACEMAKERS APPROVAL FOR THE
03/25/97 SOFTWARE (CPI) GUIDANT, CORP. VIGOR MODEL 2880
APPLICATION ST. PAUL, MN SOFTWARE APPLICATION
VERSION 3.0 55112-5798 VERSION 3.0, TO BE
USED WITH MODEL 2950
OR MODEL 2901
PROGRAMMER/RECORDER/
MONITOR DEVICES.
P940035/S001 MATRITECH MATRITECH, INC. APPROVAL FOR THE
03/19/97 NMP227 TEST CHANGE IN SPECIMEN
KIT NEWTON, MA COLLECTION TO A
02169 SINGLE VOID OF URINE,
COLLECTED BETWEEN
MIDNIGHT AND NOON,
WHICH WILL BE TESTED
USING THE MATRITECH
NMP227 TEST KIT.
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