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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGORE VIABAHN ENDOPROSTHESIS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff, AZ 86002
PMA NumberP040037
Supplement NumberS074
Date Received10/14/2014
Decision Date01/08/2015
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A 7.5 CM ENDOPROSTHESIS LENGTH IN 5-8 MM AND 9 MM DIAMETER CONFIGURATIONS, WITH AND WITHOUT HEPARIN, ON BOTH THE 0.035 GUIDEWIRE CATHETER (75CM AND 120CM LENGTH) AND THE 0.014/0.018 GUIDEWIRE CATHETER (120CM LENGTH).
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