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PMA Final Decisions Rendered for March 2000 |
 |
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 NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
P990054 |
CHILLI COOLED ABLATION SYSTEM |
CARDIAC PATHWAYS CORP. SUNNYVALE, CA |
THE CHILLI COOLED ABLATION SYSTEM IS INDICATED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING, DELIVERING DIAGNOSTIC PACING STIMULI, RF ABLATION OF MAPPABLE VENTRICULAR TACHYCARDIAS ATTRIBUTABLE TO ISCHEMIC HEART DISEASE OR CARDIOMYOPATHY IN PATIENTS WHO HAVE FAILED DRUG THERAPY. IN ADDITION, THE CHILLI CATHETER WITH TRACKING IS USED WITH THE ARRHYTHMIA MAPPING AND TRACKING SYSTEM TO PROVIDE CATHETER LOCATION INFORMATION. |
| PMA Supplemental Approvals | |||
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
N50510/S121 |
VITEK 2 GRAM NEGATIVE AST FOR MEROPENEM |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC MEROPENEM AT CONCENTRATIONS OF 0.5, 4, AND 16 UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S122 3/20/00 180-DAY |
VITEK 2 GRAM NEGATIVE AST FOR CEFTIZOXIME |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC CEFTIZOXIME AT CONCENTRATIONS OF 2, 8, AND 32UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S123 3/20/00 |
VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC NALIDIXIC ACID AT CONCETRATIONS OF 8, 16, AND 32UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S124 3/20/00 180-DAY |
VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN / CLAVULANIC ACID |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC AMOXICILLIN/CLAVULANI C ACID AT CONCENTRATIONS OF 4/2, 16/8, AND 32/16UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S125 3/31/00 180-DAY |
VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN / SULBACTAM |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
THIS DEVICE WILL BE MARKETED AS VITEK 2 WHICH TESTS FOR THE ANTIBIOTIC AMPICILLIN/SULBACTAM AT CONCENTRATIONS OF 4/2, 8/4, 16/8 AND 64/32 MICROGRAMS PER MILLILITER. |
|
N50510/S126 |
VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN |
BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
THIS DEVICE WILL BE MARKETED UNDER THE TRADENAME VITEK 2 AND ADDS THE ANTIBIOTIC CEFAZOLIN AT CONCENTRATIONS 4,8,AND 16 MICROGRAMS PER MILLILETER TO THE VITEK 2 GRAM POSITIVE SUSCEPTIBILITY TEST SYSTEM. |
| P830055/S068 3/6/00 180-DAY |
LCS TOTAL KNEE SYSTEM |
DEPUY, INC. WARSAW, IN 46581 |
EXPRESS SUPPLEMENT APPROVAL FOR MANUFACTURING FACILITY LOCATED AT DEPUY (IRELAND) LTD., LOUGHBEG, RINGASKIDDY, CORK, IRELAND. |
| P830055/S069 3/16/00 REAL-TIME |
LCS(R) TOTAL KNEE SYSTEM DESIGN MODIFICATION TO ROTATING PLATFORM BEARINGS |
DEPUY ORTHOPAEDICS, INC. WARSAW, IN 46581 |
APPROVAL FOR A DESIGN MODIFICATION TO THE PROXIMAL ARTICULAR SURFACE OF THE LCS ROTATING PLATFORM BEARINGS TO MATCH THE GEOMETRY OF THE PFC SIGMA FEMORAL COMPONENTS THAT ARE IMPLANTED USING SLIGHTLY DIFFERENT DISTAL CUTS THAN THE CURRENT LCS FEMORAL COMPONENTS. |
| P830055/S070 3/30/00 180-DAY |
LCS TOTAL KNEE SYSTEM |
DEPUY ORTHOPAEDICS, INC. WARSAW, IN 46581 |
APPROVAL FOR THE ADDITIONAL MANUFACTURING FACILITY LOCATED AT DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, RAYNHAM, MASSACHUSETTS. |
| P830060/S046 3/10/00 180-DAY |
VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR THE USE OF A MODIFIED SUTURE SLEEVE. |
| P840001/S044 3/21/00 REAL-TIME |
ITREL II MODEL 7424 NEUROSTIMULATOR |
MEDTRONIC, INC. MINNEAPOLIS, MN 55421 |
APPROVAL FOR DEVICE AND MANUFACTURING PROCESS CHANGES TO THE EXISTING MODEL 7424 ITREL II NEUROSTIMULATOR, FOR USE IN CONJUNCTION WITH THE MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM. |
| P850007/S020 3/9/00 180-DAY |
PHYSIO STIM AND PHYSIO STIM LITE BONE GROWTH STIMULATORS |
ORTHOFIX, INC. RICHARDSON, TX 75081 |
APPROVAL TO MODIFY THE DEVICE LABELING TO INCLUDE PATIENT REGISTRY DATA IN ADDITION TO THE ORIGINAL DATA CONTAINED IN THE PMA |
| P860003/S033 3/6/00 180-DAY |
UVADEX(R) STERILE LIQUID |
THERAKOS, INC., JOHNSON & JOHNSON EXTON, PA 19341 |
APPROVAL FOR A LABELING CHANGE TO REFLECT THE USE OF UVADEX, THE STERILE LIQUD FORMULATION OF 8-METHOXYPSORALEN. |
| P860019/S159 3/24/00 SPECIAL |
PTCA CATHETER |
BOSTON SCIENTIFIC/SCIMED MAPLE GROVE, MN 55311 |
APPROVAL FOR A LABELING CHANGE THAT ADVISES THE USER NOT TO USE THE PTCA CATHETER IF THE PROXIMAL SHAFT HAS BEEN BENT OR KINKED. |
| P890040/S005 3/23/00 180-DAY |
SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES |
UNILENS CORP., USA LARGO, FL 33777 |
APPROVAL FOR A MANUFACTURING SITE LOCATED AT UNILENS CORPORATION, LARGO, FLORIDA. |
| P890064/S007 3/16/00 180-DAY |
DIGENE HYBRID CAPTURE II HIGH-RISK HPV DNA TEST |
DIGENE DIAGNOSTICS, INC. SILVER SPRING, MD 20904 |
APPROVAL FOR REMOVAL OF THE REAGENT COMPONENT "PROBE A" AND INDICATION NUMBER 1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DIGENE HIGH-RISK HPV DNA TEST USING HYBRID CAPTURE. |
| P900023/S030 3/13/00 180-DAY |
ABIOMED BVS 5000 BI-VENTRICULAR SUPPPORT SYSTEM |
ABIOMED CARDIOVASCULAR, INC. DANVERS, MA 1923 |
APPROVAL FOR USING MODEL EWS300P-24 AC/DC CONVERTER MANUFACTURED BY LAMBDA, MELVILLE, NY AS AN ALTERNATE AC/DC CONVERTER IN THE BVS 5000 AND BVS 5000I CONSOLES. |
| P900043/S022 3/2/00 180-DAY |
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM |
CORDIS CORP. MIAMI LAKES, FL 33014 |
MODIFICATION OF THE MANUFACTURING PROCESS TO FORM BALLOON SHOULDERS AT THE DISTAL AND PROXIMAL ENDS OF THE STENT. |
| P900056/S036 3/8/00 SPECIAL |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |
BOSTON SCIENTIFIC CORP. REDMOND, WA 98052 |
APPROVAL FOR AN ADDITIONAL STEP TO THE INSPECTION PROCEDURE OF THE INFUSION TUBE TO ENSURE ADEQUATE CLEANING OF THE COMPONENT. |
| P900056/S037 3/8/00 SPECIAL |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM |
BOSTON SCIENTIFIC CORP. REDMOND, WA 98052 |
APPROVAL TO ADD AN ADDITIONAL STEP TO THE INSPECTION PROCEDURE OF THE INSERT HUB TO CONFIRM THAT THE DEPTH OF THE GROOVES ARE WITHIN SPECIFICATION. |
| P900056/S038 3/24/00 SPECIAL |
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM |
BOSTON SCIENTIFIC CORP. REDMOND, WA 98052 |
APPROVAL OF A CHANGE IN THE ACCEPTANCE CRITERION, FROM <= 15 PSI TO <= 13PSI, FOR THE QUALITY ASSURANCE WET TEST FOR THE A19 MODEL. |
| P900061/S041 3/2/00 180-DAY |
GEM IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR |
MEDTRONIC, INC. MINNEAPOLIS, MN 55432 |
APPROVAL FOR MODIFICATIONS TO THE CIRCUITRY OF THE MEDTRONIC MODEL 7227 GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. |
| P900066/S003 3/16/00 180-DAY |
PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY |
SCOTT MEDICAL PRODUCTS GROUP PLUMSTEADVILLE,, PA 18949 |
1)CHANGE IN MANUFACTURING SITE; 2)ALTERNATE SYNTHESIS ROUTE FOR PERFLUOROPROPANE; AND 3) CHANGING RELEASE SPECIFICATION FOR THE PERFLUOROPROPANE GAS. |
| P910001/S017 3/17/00 135-DAY |
ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT |
SPECTRANETICS CORP. COLORADO SPRINGS, CO 80907 |
THE 135-DAY SUPPLEMENT REQUESTED APPROVAL FOR THE ADDITION OF ETHYLENE OXIDE STERILIZATION EQUIPMENT. |
| P910065/S002 3/3/00 180-DAY |
AIA PACK PA |
TOSOH MEDICS, INC. SOUTH SAN FRANCISCO, CA 94080 |
APPROVAL FOR THE ADDITION OF THE AIA 600 II ANALYZER INSTRUMENT TO THE LIST OF APPROVED ANALYZERS USING THE AIA-PACK PA ASSAY. |
| P910066/S014 3/9/00 REAL-TIME |
ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR |
ORTHOLOGIC CORP. TEMPE, AZ 85281 |
APPROVAL FOR REVISIONS TO THE PHYSICIAN MANUAL AND PACKAGE INSERT, AND THE PATIENT MANUAL. |
| P910073/S029 3/10/00 180-DAY |
ENDOTAK(R) TRANSVENOUS DEFIBRILLATION LEAD SYSTEM |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR THE USE OF A MODIFIED SUTURE SLEEVE. |
| P910077/S030 3/10/00 180-DAY |
VENTAK PRX AICD SYSTEM |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR THE USE OF A MODIFIED SUTURE SLEEVE. |
| P930038/S019 3/8/00 180-DAY |
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE |
DAIG CORP. MINNETONKA, MN 55345 |
APPROVAL FOR THE 6F ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME 6F ANGIO-SEAL(TM) HEMOSTATIC PUNCTURE CLOSURE DEVICE AND IS INDICATED FOR CLOSING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY PROCEDURES USING A RETROGRADE APPROACH AND A 6 FRENCH OR SMALLER PROCEDUREAL SHEATH. THE ANGIO-SEAL (TM) DEVICE REDUCES THE TIMES TO HEMOSTASIS, AMBULATION AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS). |
| P930038/S023 3/1/00 180-DAY |
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE |
ST. JUDE MEDICAL, INC. MINNETONKA, MN 55345 |
APPROVAL FOR MODIFICATIONS TO THE ANCHOR FAILURE YIELD STRENGTH SPECIFICATIONS. |
| P930038/S024 3/23/00 180-DAY |
ANGIO-SEAL |
DAIG CORP. MINNETONKA, MN 55345 |
APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS INTERNATIONAL, INC., GURNEE, ILLINOIS. |
| P950001/S005 3/10/00 180-DAY |
SELUTE(R) STEROID-ELUTING LEAD |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL IS FOR THE USE OF A MODIFIED SUTURE SLEEVE. |
| P950005/S007 3/13/00 REAL-TIME |
CELSIUS II DIAGNOSTIC/ABLATI ON DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR |
CORDIS WEBSTER, INC. DIAMOND BAR, CA 91765 |
APPROVAL FOR A SIX-MONTH SHELF LIFE. |
| P950015/S005 3/8/00 180-DAY |
THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER) |
PLC MEDICAL SYSTEMS, INC. FRANKLIN, MA 2038 |
APPROVAL FOR SPECIFIC SOFTWARE REVISIONS ADDRESSED TO DISARMING THE LASER AFTER IT HAS FIRED AND TO RESOLVING A MINOR Y2K PROBLEM. |
| P950019/S009 3/2/00 180-DAY |
RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION |
UNITED STATES SURGICAL CORP. NORWALK, CT 6856 |
MODIFIED INDICATIONS FOR USE FOR THE RAY TFC AND UNITE THREADED FUSION CAGE WITH INSTRUMENTATION. THESE DEVICES ARE INDICATED FOR USE WITH AUTOGENOUS BONE GRAFTS IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE OR TWO LEVELS FOR L2 TO S1. |
| P950034/S014 3/23/00 REAL-TIME |
SEPRAFILM BIORESORBABLE MEMBRANE |
GENZYME CORP. CAMBRIDGE, MA 2139 |
APPROVAL FOR THE USE OF DENATURED ALCOHOL 3C TO PRECIPITATE THE SODIUM HYALURONATE/CARBOXYME THYLCELLULOSE POWDER (HA/CMC) RATHER THAN ETHYL ALCOHOL. |
| P960004/S010 3/29/00 180-DAY |
THINLINE ENDOCARDIAL PACING LEADS |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR THE USE OF NUSIL MED 4870 AS AN ALTERNATE MATERIAL FOR THE SUTURE SLEEVE AND EXTENSION OF THE SHELF LIFE OF YOUR DEVICES TO 4 YEARS. |
| P960006/S003 3/10/00 180-DAY |
SWEET TIP RX STEROID ELUTING LEAD |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR THE USE OF A MODIFIED SUTURE SLEEVE. |
| P960007/S013 3/16/00 180-DAY |
TRANSCYTE |
ADVANCED TISSUE SCIENCES LAJOLLA, CA 92037 |
APPROVAL TO EXTEND THE EXPIRATION DATE TO 20 MONTHS AND TO REVISE PRODUCT LABELING TO INDICATE THAT THE DEVICE MAY BE STORED BY THE END USER AT TEMPERATURES BETWEEN -70C AND -20C. |
| P960009/S009 3/21/00 REAL-TIME |
ACTIVA TREMOR CONTROL SYSTEM |
MEDTRONIC, INC. MINNEAPOLIS, MN 55421 |
APPROVAL FOR DEVICE AND MANUFACTURING PROCESS CHANGES TO THE EXISTING MODEL 7424 ITREL II NEUROSTIMULATOR, AND REBRANDING OF THIS DEVICE UNDER THE NEW TRADENAME, SOLETRA MODEL 7426 NEUROSTIMULATOR, FOR USE IN CONJUNCTION WITH THE EXISTING MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM. |
| P960013/S007 3/7/00 180-DAY |
TENDRIL SDX |
PACESETTER, INC. SYLMAR, CA 91392 |
APPROVAL FOR THE TENDRIL SDX MODEL 1488/K/TC ENDOCARDIAL, STEROID-ELUTING, ACTIVE-FIXATION PACING LEADS. |
| P960042/S005 3/17/00 135-DAY |
SPECTRANETICS LASER SHEATHS (SLS) |
SPECTRANETICS CORP. COLORADO SPRINGS, CO 80907 |
THE 135-DAY SUPPLEMENT REQUESTED APPRROVAL FOR THE ADDITION OF ETHYLENE OXIDE STERILIZATION EQUIPMENT. |
| P960043/S021 3/2/00 180-DAY |
CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES |
PERCLOSE, INC. REDWOOD CITY, CA 94063 |
EXPRESS SUPPLEMENT APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY LOCATED AT GRIFFITH MICRO SCIENCE, LOS ANGELES, CALIFORNIA. |
| D970003/S006 3/10/00 180-DAY |
DISCOVERY II, INTELIS II AND MODEL 2891 CONSULT SOFTWARE VERSION 1.15 |
GUIDANT CORP. ST. PAUL, MN 55112 |
APPROVAL FOR SEVERAL NEW MODELS AND SOFTWARE FOR DISCOVERY II, INTELIS II AND MODEL 2891 CONSULT SOFTWARE VERSION 1.14 |
| P970004/S008 3/9/00 REAL-TIME |
INTERSTIM SYSTEM FOR URINARY CONTROL |
MEDTRONIC, INC. MINNEAPOLIS, MN 55421 |
APPROVAL FOR 1)ELIMINATION OF THE OR SCREENING CABLE FROM THE MODEL 3080 AND 3886 LEAD KITS, 2) TO USE THE GENERIC TERM "FLUOROPOLYMER" IN PLACE OF "PTFE," AND 3) TO MAKE NUMEROUS MINOR REVISIONS TO THE PHYSICIAN AND HOSPITAL STAFF MANUAL FOR THE MODEL 3012 QUADRIPOLAR NEUROSTIMULATOR, MODELS 3080 AND 3886 LEADS, AND MODEL 3095 EXTENSION. |
| P970008/S014 3/2/00 180-DAY |
UROLOGIX TARGIS SYSTEM |
UROLOGIX, INC. MINNEAPOLIS, MN 55447 |
APPROVAL FOR A MODIFICATION TO THE SOFTWARE TO ADD THE AUTO-CONTROL OPTION TO THE TARGIS SYSTEM TREATMENT. |
| P970029/S003 3/22/00 SPECIAL |
ECLIPSE TMR HOLMIUN LASER SYSTEM |
ECLIPSE SURGICAL TECHNOLOGIES, INC. SUNNYVALE, CA 94089 |
APPROVAL OF A NEW TEST FIBER AND FOUR NEW LABELS. |
| P970034/S005 3/27/00 180-DAY |
POSTERIOR CHAMBER INTRAOCULAR LENSES |
OPHTHALMIC INNOVATIONS INTL., INC. CLAREMONT, CA 91711 |
APPROVAL FOR REDUCING THE FREQUENCY OF ETHYLENE CHLOROHYDRIN RESIDUAL TESTING FROM A QUARTERLY BASIS TO AN ANNUAL BASIS. |
| P980001/S011 3/16/00 180-DAY |
NIR W/SOX PREMOUNTED STENT SYSTEM |
BOSTON SCIENTIFIC CORP. NATICK, MA 1760 |
APPROVAL FOR THE NIR (TM) W/SOX(TM) PREMOUNTED STENT SYSTEM. |
| P980001/S012 3/20/00 180-DAY |
NIR PREMOUNTED STENT SYSTEMS |
BOSTON SCIENTIFIC CORP. NATICK, MA 1760 |
APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE STATEMENT AND THE INSTRUCTIONS FOR USE (IFU) TO INCLUDE THE RESULTS OF THE NINE-MONTH FOLLOW-UP OF THE NIRVANA CLINICAL TRIAL FOR THE NIR ON RANGER AND NIR PRIMO PREMOUNTED STENT SYSTEMS. |
| P980009/S005 3/23/00 180-DAY |
MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT |
BOSTON SCIENTIFIC/SCIMED MAPLE GROVE, MN 55311 |
APPROVAL FOR THE ALTERNATE STERILIZATION FACILITY LOCATED AT GAMMASTER IRELAND LTD., WESTPORT, COUNTY MAYO, IRELAND. |
| P980022/S003 3/10/00 REAL-TIME |
CONTINUOUS GLUCOSE MONITORING SYSTEM |
MINIMED TECHNOLOGIES, INC. SYLMAR, CA 91342 |
APPROVAL FOR THE SEN-SERTER AUTO INSERTER TO BE USED WITH THE MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM AS AN AID FOR INSERTION OF THE MIMIMED GLUCOSE SENSOR. |
| P980037/S002 3/17/00 SPECIAL |
POSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE |
POSSIS MEDICAL, INC. MINNEAPOLIS, MN 55433 |
APPROVAL FOR THE ADDITION OF A LABEL TO THE CURRENT INVENTORY OF THE LF 140 CATHETER WHICH READS "CAUTION: DO NOT INJECT FLUIDS IN CATHETER OUTFLOW LUMEN". |
| P990017/S003 3/29/00 180-DAY |
EVT ABDOMINAL AORTIC TUBE/EVT ABDOMINAL AORTIC BIF |
GUIDANT CORP. MENLO PARK, CA 94025 |
APPROVAL FOR SHELF LIFE EXTENSION TEST PROTOCOL. |
| P990017/S005 3/24/00 REAL-TIME |
ANCURE ENDOGRAFT SYSTEM/ANCURE ILIAC BALLOON CATHETER |
GUIDANT CARDIAC AND VASCULAR SURGERY MENLO PARK, CA 94025 |
APPROVAL TO ADD THE ANCURE BIFURCATED ENDOGRAFT WITH DIFFERENTIAL LIMB LENGTHS TO THE PRODUCT LINE. |
| 30-Day Notices (A 135 Day Supplement was not required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
|
P850079/S036 3/23/00 |
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR |
COOPERVISION, INC. FREMONT, CA 94538 |
ALTERNATE MANUFACTURING PROCESS |
|
P950019/S011 3/30/00 |
RAY THREADED FUSION CAGE(TFC-TM) DEVICE |
UNITED STATES SURGICAL CORP. NORWALK, CT 6856 |
REMOVAL OF THE POST STERILIZATION INSPECTION FOR THE RAY THREADED FUSION CAGE WITH INSTRUMENTATION. |
|
P970020/S020 3/20/00 |
ACS MULTI-LINK DUET & TRISTAR CORONARY STENT |
GUIDANT CORP. TEMECULA, CA 92591 |
CHANGES IN THE ELECTRO- POLISHING PARAMETERS FOR THE STENT |
|
P980031/S003 3/17/00 |
INTACS CORNEAL |
KERAVISION, INC. FREMONT, CA 94538 |
CHANGES TO THE TUMBLE POLISHING AND FINAL CLEANING PROCESS |
*Real-Time Supplement
**135 Day Supplement
# "Special – Changes Being Effected"
# Panel-Track Supplement
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 55
30-Day Notices: 4
Summary of PMA Originals Under Review|
Total Under Review: 102
Total Active: 54
Total On Hold: 48
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 198
Total Active: 124
Total On Hold: 74
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 3
Supplements: 61
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 55Filing to Approval:
FDA Time 104 Days
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