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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 WITH HEPARIN BIOACTIVE S4URFACE
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff, AZ 86002
PMA NumberP040037
Supplement NumberS004
Date Received03/05/2007
Decision Date07/31/2007
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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