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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 NumberS152
Date Received02/14/2022
Decision Date05/26/2022
Product Code NIP 
Advisory Committee Cardiovascular
Clinical TrialsNCT01108861
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the labeling update to include the final results of the RELINE MAX New Enrollment Study (ISR 04-04)
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