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PMA Final Decisions Rendered for April 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 |
| P950020
04/18/00 |
(BSDB) PTCA SURGICAL DILATION BALLOON CATH. | INTERVENTIONAL TECHNOLOGIES, INC. SAN DIEGO, CA 92123 |
THIS DEVICE IS INDICATED FOR THE DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FOLLOWING CHARACTERISTICS: DISCRETE (< MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH) WITH A REFERENCE VESSEL DIAMETER RANGING FROM 2.0 MM TO 4.0 MM; READILY ACCESSIBLE TO THE DEVICE; LIGHT TO MODERATE TORTUOSITY OF PROXIMAL VESSEL SEGMENT, NON-ANGULATED LESION SEGMENT (<45 DEGREES), SMOOTH ANGIOGRAPHIC CONTOUR; AND ABSENCE OF ANGIOGRAPHICALLY-I VISIBLE THROMBUS AND/OR CALCIFICATION. |
| P990013 04/02/00 |
COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | STARR SURGICAL CO. MONROVIA, CA 91016 |
THIS DEVICE IS INDICATED FOR THE CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION CATARACT EXTRACTION. THE LENS IS TO BE IMPLANTED IN THE POSTERIOR CHAMBER AND IN THE CAPSULAR BAG THROUGH A TEAR-FREE CAPSULORHEXIS (CIRCULAR TEAR ANTERIOR CAPSULOTOMY). |
| P990048 04/12/00 |
ZEISS VISULAS 690 AND VISULINK PDT/900 LASER SYSTEM | HOGAN & HARTSON WASHINGTON, DC 20004 |
APPROVAL FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION. |
| P990049 4/12/00 |
COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM | QLT PHOTOTHERAPEUTICS INC. SEATTLE, WA 98101 |
APPROVAL FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION. |
|
PMA Supplemental Approvals |
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| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| N50510/S127 4/5/00 180-DAY |
VITEK 2 GRAM NEGATIVE AST FOR AMPICILLIN | BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC AMPICILLIN AT CONCENTRATIONS OF 4, 8, AND 21 UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S128 4/17/00 180-DAY |
VITEK 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID | BIOMERIEUX, INC. HAZELWOOD, MO 63042 |
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TICARCILLIN/ CLAVULANIC ACID AT CONCENTRATIONS OF 8/2, 32/2, 64/2 UG/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| N50510/S129 4/26/00 180-DAY |
VITEK® 2 GRAM NEGATIVE AST FOR IMIPENEM |
BIOMERIEUX, INC HAZELWOOD, MO 63042 |
THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST CARDS. APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC IMIPENEM AT CONCENTRATIONS OF 2, 4 AND 16 MICROGRAMS/ML TO THE VITEK 2 GRAM NEGATIVE SUSCEPTIBILITY TEST SYSTEM. |
| P830055/S072 4/28/00 REAL-TIME |
LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE | DEPUY ORTHOPAEDICS, INC. WARSAW, IN 46581 | APPROVAL TO ALLOW THE OPTION OF MANUFACTURING ALL APPROVED LCS TOTAL KNEE SYSTEM ULTRA DEVICES HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) COMPONENTS VACUUM-PACKAGED IN FOIL BAGS AND GAMMA RADIATION STERILIZED (THE GVF PROCESS). |
| P840001/S046 4/12/00 REAL-TIME |
ITREL SPINAL CORD STIMULATION SYSTEM | MEDTRONIC, INC
MINNEAPOLIS, MN 55421 |
APPROVAL FOR THE MODEL 7499 EXTENSION, SYSTEM CONNECTOR BOOT, AND EXTENSION PASSER TUNNELING SYSTEM, FOR USE IN CONJUNCTION WITH THE MEDTRONIC ITREL SPINAL CORD STIMULATION SYSTEM. ALSO, APPROVAL FOR LABELING MODIFICATIONS. |
| P860004/S045 4/14/00 REAL-TIME |
MEDTRONIC ONE PIECE VASCULAR CATHETERS | MEDTRONIC, INC
SHOREVIEW, MN |
APPROVAL FOR CHANGES IN THE ANCHOR RINGS AT THE TIP OF THE MODEL 8700A CATHETER; CHANGES TO THE CATHETER TUBING COMPOSITION; CHANGES TO THE TECHNICAL MANUAL - THE MODEL 8700A, MODEL 8700V, AND MODEL 8702 CATHETERS ARE COVERED IN THE SAME TECHNICAL MANUAL |
| P870018/S024 4/17/00 REAL-TIME |
LITHOSTAR MODULARIS | SIEMENS MEDICAL SYSTEMS, INC.
ISELIN, NJ |
APPROVAL FOR A LITHOSHARE OPTION FOR THE LITHOSTAR MODULARIS |
| P880003/S079 4/27/00 180-DAY |
RAPTOR PTCA DILATION CATHETER | CORDIS CORP
MIAMI LAKES, FL |
APPROVAL FOR THE RAPTOR PTCA CATHETER (BALLOON DIAMETERS RANGING FROM 1.5 MM TO 5.0 MM WITH LENGTHS RANGING FROM 10 MM TO 35 MM) |
| P880027/S057 4/26/00 180-DAY |
BOSTON SCIENTIFIC SCIMED PTCA CATHETERS | BOSTON SCIENTIFIC/SCIMED
MAPLE GROVE, MN |
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC IRELAND LTD., GALWAY, IRELAND AND FOR A STERILIZATION SITE LOCATED AT ISOTRON ORELAND LTD, COUNTY OFFALY, IRELAND |
| P880086/S070 4/6/00 REAL-TIME |
INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS | ST. JUDE MEDICAL, INC.
SYLMAR, CA |
APPROVAL FOR THE INTEGRITY AFX DR MODEL AND SR MODEL 5142 |
| P880086/S071 4/6/00 REAL-TIME |
AFFINITY VDR MODEL 5430 PULSE GENERATOR | ST. JUDE MEDICAL, INC.
SYLMAR, CA
|
APPROVAL FOR THE AFFINITY VDR MODEL 5430 PULSE GENERATOR |
| P890057/S013 4/11/00 180-DAY |
ELECTROMECHANICAL ENHANCEMENT TO DRIVER | SENSOR MEDICS CORP.
YORBA LINDA, CA |
APPROVAL FOR A MODIFIED 3.0 OHMS DRIVERS COIL ASSEMBLY. |
| P900009/S008 4/14/00 180-DAY |
EXOGEN 3000 | EXOGEN
PISCATAWAY, NJ |
APPROVAL FOR VARIOUS DESIGN AND MANUFACTURING CHANGES WHICH DO NOT AFFECT THE OUTPUT OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 3000. |
| P900023/S031 04/14/00 180-day |
ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM | ABIOMED CARDIOVASCULAR, INC.
DANVERS, MA 01923 |
Approval for the Abiomed BVS 5000t Bi-Ventricular Support System Transport/Backup Console |
| P90043/S019 4/6/00 180-DAY |
CROSSFLEX LC BALLOON EXPANDABLE STENT (ANGLED END/SQUARE END) WITH OVER THE WIRE DELIVERY SYSTEM | CORDIS CORP.
MIAMI LAKES, FL 33014 |
APPROVAL OF THE ADDITION OF THE ABRUPT AND THREATENED CLOSURE INDICATION FOR THE CROSS FLEX LC BALLOON EXPANDABLE STENT WITH OVER-THE-WIRE DELIVERY SYSTEM. |
| P900056/S041 4/10/00 SPECIAL |
ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM | BOSTON SCIENTIFIC CORP.
REDMOND, WA 98052 |
APPROVAL FOR A QUALITY CONTROL CHANGE THAT INCREASES THE MONITORING OF THE STRIKE BATH USED IN THE GOLD PLATING PROCESS OF THE FLOPPY GOLD GUIDE WIRE. |
| P900056/S043 4/11/00 SPECIAL |
ROTABLATOR (R) ROTATIONAL ANGIOPLASTY SYSTEM | BOSTON SCIENTIFIC CORP.
REDMOND, WA 98052
|
APPROVAL FOR A QUALITY CONTROL CHANGE THAT INCREASES THE NUMBER OF TIMES THE BURR SIZE IS VERIFIED OR MEASURED DURING THE MANUFACTURING PROCESS |
| P910058/S011 4/18/00 REAL-TIME |
ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES, MODEL C11UB | BAUSCH & LOMB, INC.
CLEARWATER, FL 33759 |
APPROVAL FOR AN ALTERNATE PACKAGING CONFIGURATION COMPRISING A DIFFERENT LENS CARRIER DESIGN AND A SINGLE, RATHER THAN DOUBLE, AUTOCLAVABLE POUCH. |
| P910062/S001 04/20/00 |
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) | VISX, INC.
SANTA CLARA, CA 95051 |
The device, as modified, will be real-time marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK). |
| P910073/S028 4/20/00 REAL-TIME |
ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD | GUIDANT CORP.
ST. PAUL, MN 55112 |
APPROVAL FOR CHANGES TO THE HELIX MECHANISM OF THE ENDOTAK ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD. |
| P910073/S031 | ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD, SQ PATCH LEAD, EPICARDIAL PATCHES | GUIDANT CORP.
ST. PAUL, MN 55112 |
APPROVAL FOR AN EXTRA LEAD PORT TO THE ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD MODEL 0049 AND A MODIFIED DF-1 TERMINAL OF: THE ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD MODEL 0049; ENDOTAK SQ PATCH LEAD MODEL0047; ENDOTAK SQ ARRAY SUBCUTANEOUS LEAD MODEL 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition. |
| P910073/S031 04/11/00 REAL-TIME |
ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES | GUIDANT CORP.
ST. PAUL, MN |
Approval for an extra lead port to the ENDOTAK SQ Array XP subcutaneous Lead Model 0049 and a modified DF-1 terminal of: the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049; ENDOTAK SQ Patch Lead Model 0047; ENDOTAK SQ Array Subcutaneous Lead Model 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial Patches Models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition. |
| P920004/S012 4/10/00 SPECIAL |
VASOSEAL ES (ES DEVICE) | DATASCOPE CORP.
MONTVALE, NJ 07645 |
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE. |
| P930016/S011 4/20/00 REAL-TIME |
VISX STARR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) | VISX, INC.
SANTA CLARA, CA 95051 |
THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) AND IS INDICATED FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK), MYOPIC, ASTIGMATIC, AND HYPEROPIC (SPHERE ONLY) PHOTOREFRACTIVE KERATECTOMY (PRK) AND MYOPIC AND ASTIGMATIC LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK). |
| P930038/S022 4/6/00 180-DAY |
ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE | ST.JUDE MEDICAL INC.
MINNETONKA, MN 55345 |
APPROVAL FOR A MODIFICATION TO THE 8F ANGIO-SEAL DEVICE TO INCLUDE A MONOFOLD DESIGN FOR THE INSERTION SHEATH COMPONENT. |
| P940002/S003 4/18/00 SPECIAL |
NATURAL KNEE & NATURAL KNEE II | SULZERMEDICA
AUSTIN, TX 78717 |
APPROVAL FOR USE OF FORGED TI ALLOY AS A MATERIAL FOR THE CONSTRUCTION OF THE STEMMED TIBIAL BASE PLATE COMPONENT OF THE DEVICES. |
| P950014/S020 4/13/00 180-DAY |
PROSTATRON
30071 |
EDAP TECHNOMED, INC.
NORCROSS, GA 30071 |
approval for changes to the prostatron software program to include the 30-minute tumt treatment protocol. |
| P960009/S010 4/12/00 180-DAY |
ACTIVA TREMOR CONTROL SYSTEM | MEDTRONIC, INC.
MINNEAPOLIS, MN 55421 |
APPROVAL FOR THE MODEL 7482 EXTENSION, CONNECTOR BOOT, AND EXTENSION PASSER TUNNELING SYSTEM, FOR USE IN CONJUNCTION WITH THE EXISTING MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM. ALSO APPROVAL FOR LABELING MODIFICATIONS. |
| P960009/S012 4/26/00 SPECIAL |
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM | MEDTRONIC, INC.
MINNEAPOLIS, MN 55421
|
APPROVAL TO CORRECT AN INACCURACY IN MEDTRONIC'S TECHNICAL MANUAL, PATIENT MANUAL AND OTHER CORRESPONDING DOCUMENTATION. |
| P960025/S003 4/10/00 REAL-TIME |
LUMBAR I/F CAGE WITH VSP SPINE SYSTEM | DEPUY ACROMED
RAYNHAM, MA |
APPROVAL OF ADDITIONAL SIZES FOR THE LUMBAR I/F CAGE. |
| P970010/S002 4/28/00 180-DAY |
NORIAN SRS CEMENT | SYNTHES (USA)
PAOLI, PA 19301 |
APPROVAL OF THE REAL TIME SHELF LIFE PROTOCOL FOR PURPOSES OF EXTENDING THE SHELF LIFE |
| P970015/S005 4/12/00 REAL-TIME |
INTER FIX RP THREADED FUSION DEVICE | SOFAMOR DANEK
MEMPHIS, TN 38132 |
APPROVAL FOR THE INTER FIX RP THREADED FUSION DEVICE |
| P970015/S008 4/12/00 REAL-TIME |
INTER FIX THREADED FUSION DEVICE | SOFAMOR DANEK
MEMPHIS, TN 38132
|
APPROVAL OF THE 22 MM AND 24 MM DIAMETER INTERFIX THREADED FUSION DEVICE. |
| P970015/S009 4/12/00 REAL-TIME
|
INTER FIX RP THREADED FUSION DEVICE | SOFAMOR DANEK
MEMPHIS, TN 38132
|
APPROVAL FOR THE 22 AND 24 MM DIAMETER INTERFIX RP THREADED FUSION DEVICE. |
| P970034/S004 4/28/00 180-DAY |
POSTERIOR CHAMBER INTRAOCULAR LENSES | OPHTHALMIC INNOVATIONS INTL., INC.
CLAREMONT, CA 91711 |
approval for allergen surgical to distribute the models rs-50b, rs-55b, rs-60b, rs-65, sp-60a, and sp-65a2 ultraviolet-absorbing posterior chamber intraocular lenses as allergan's duralens models 52, 53, 54, 59, 60 and 65t respectively. |
| P970053/S002 4/14/00 EXPEDITED |
NIDEK EC-5000 EXCIMER LASER SYSTEM | NIDEK TECHNOLOGIES INC.
PASADENA, CA 91105 |
INDICATIONS FOR USE OF THE NIDEK EC-5000 EXCIMER LASER SYSTEM |
| P970058/S006 4/17/00 180-DAYS |
MAGECHECKER M1000 SYSTEM | R2 TECHNOLOGY
LOS ALTOS, CA 94022 |
APPROVAL FOR A SOFTWARE CHANGE THAT IMPROVES THE DEVICE SENSITIVITY FOR DETECTING MASSES AND REDUCES THE NUMBER OF EXTRANEOUS MAKS PRODUCED PER CASE. |
| P980001/S018 4/25/00 SPECIAL |
NIR PREMOUNTED STENT SYSTEM | BOSTON SCIENTIFIC/SCIMED
MAPLE GROVE, MN 55311 |
APPROVAL FOR AN ADDITION OF A NOTE TO THE INSTRUCTIONS FOR USE OF THE NIR PRIMO PREMOUNTED STENT SYSTEM. |
| P980037/S001 4/3/00 180-DAY |
ANGIOJET RHEOLYTIC TFI40 THROMBECTOMY CATHETER | POSSIS MEDICAL, INC.
MINNEAPOLIS, MN 55433 |
APPROVAL FOR THE MODEL TF140 CATHETER, A MODIFICATION TO THE CURRENTLY APPROVED LF140 CATHETER. |
| P990010/S001 4/20/00 REAL-TIME |
VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) | VISX, INC.
SANTA CLARA, CA 95051 |
THE DEVICE, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER) AND IS INDICATED FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK), MYOPIC, ASTIGMATIC, AND HYPEROPIC (SPHERE ONLY) PHOTOREFRACTIVE KERATECTOMY (PRK) AND MYOPIC AND ASTIGMATIC LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK). |
| P990017/S006 4/14/00 180-DAY |
ANCURE ENDOGRAFT SYSTEM/ILIAC BALLOON CATHETER | GUIDANT CARDIAC AND VASCULAR SURGERY
MENLO PARK, CA 94025 |
APPROVAL FOR THE ADDITION OF A HYDROPHILIC COATING WITH THE TRADE NAME HYDRACOAT TO THE OUTER SURFACE OF THE ANCURE DELIVERY CATHETER JACKET. |
|
30-Day Notices (A 135-Day Supplement was not required) |
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| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P860019/S161 4/26/00 |
SCIMED PTCA CATHETERS | BOSTON SCIENTIFIC/SCIMED
MAPLE GROVE, MN 55311 |
CHANGE IN MANUFACTURING METHOD FROM AN ACID-ETCH TO A CENTERLESS GRINDING PROCESS FOR THE DISTAL TAPER IN THE COREWIRE SUBASSEMBLY IN FIXED WIRE MODELS OF PTCA CATHETERS |
| P900056/S039 4/1/00 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM | BOSTON SCIENTIFIC CORP.,
REDMOND, WA 98052 |
CHANGE IN A VESSEL USED IN THE AIR/STREAM STERILIZATION OF THE ROTAGLIDE LUBRICANT. |
| P900056/S040 4/1/00 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM | BOSTON SCIENTIFIC CORP.,
REDMOND, WA 98052
|
CHANGE TO THE MANUFACTURING PROCESS OF THE FLOPPY GOLD GUIDE WIRE |
| P900056/S042 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM | BOSTON SCIENTIFIC CORP.,
REDMOND, WA 98052
|
CHANGE TO THE MANUFACTURING PROCESS OF THE ROTABLATOR ROTALINK ADVANCER/CATHETER. |
| P950022/S008 4/19/00 |
TVL AND SPL LEAD SYSTEM | ST. JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIV.
SUNNYVALE, CA 94086 |
DESIGNATION OF ALTERNATE VENDORS OF THE SILICONE MATERIALS AND MEDICAL ADHESIVES USED IN THE TVL AND SPL TACHYCARDIA LEADS. |
| P980046/S002 4/12/00 |
HEPATITIS C CHECK TESTING SERVICE | HOME ACCESS HEALTH CORP.
HOFFMANN ESTATES, IL 60195 |
AS A FINAL PACKAGING OPTION, THE OUTER PACKAGING OF THE HEPATITIS C CHECK PRODUCT MAY BE ASSEMBLED IN A SOFTPAK PACKAGE OR THE CURRENTLY APPROVED PAPERBOARD PACKAGING WHEN SHIPPED DIRECTLY TO CLIENTS. |
| P990020/S004 4/12/00 |
THE ANEURX ™ STENT GRAFT SYSTEM | MEDTRONIC AVE, PERIPHERAL TECHNOLOGIES
SANTA ROSA, CA 95407 |
ADDITION OF SUPPLIERS OF SEWN STENT GRAFTS. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 41
30-Day Notices: 7
Summary of PMA Originals Under Review
Total Under Review: 100
Total Active: 45
Total On Hold: 55
Number Greater Than 180 Days: 0
Summary of PMA Supplements Under Review
Total Under Review: 195
Total Active: 125
Total On Hold: 70
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 4
Supplements: 46
Summary of PMA Supplement Approval/Denial Decision Times
Number of Approvals: 41
Number of Denials: 0
Average Days From Receipt to Decision (Total Time): 86.6
Summary of PMA Supplement Approval/Denial Decision Times
Average Days From Filing to Decision
FDA Time: 84.2
MFR Time: 2.4
Updated 1/16/2001
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