Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE S4URFACE |
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 | S004 |
Date Received | 03/05/2007 |
Decision Date | 07/31/2007 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OR THE ADDITION OF A HEPARIN COATING ON THE GORE VIABAHN ENDOPROSTHESIS, REFERRED TO AS THE HEPARIN BIOACTIVE SURFACE. |
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