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Device | GORE VIABAHN ENDOPROSTHESIS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 FLAGSTAFF, AZ 86002-0500 |
PMA Number | P040037 |
Supplement Number | S007 |
Date Received | 11/20/2007 |
Decision Date | 08/14/2008 |
Product Code |
NIP |
Docket Number | 08M-0467 |
Notice Date | 08/21/2008 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF AN EXTENSION OF THE INDICATIONS FOR USE TO INCLUDE ILIAC ARTERIAL LESIONS. THE DEVICE IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0-12.0 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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