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Device | GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE |
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 | S050 |
Date Received | 04/29/2013 |
Decision Date | 10/18/2013 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01263665
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A 25CM LENGTH FOR THE 5-8MM DIAMETER ENDOPROSTHESES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND IS INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN SUPERFICIAL FEMORAL ARTERY LESIONS UP TO 230 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 7.5 MM. THE GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE ARE ALSO INDICATED FOR IMPROVING BLOOD FLOW IN PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE IN ILIAC ARTERY LESIONS UP TO 80 MM IN LENGTH WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 12 MM. |
Post-Approval Study | Show Report Schedule and Study Progress |