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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® FORTEGRA Venous Stent
Generic NameStent, vena cava
ApplicantW. L. Gore & Associates, Inc.
1505 N Fourth St.
Flagstaff, AZ 86004
PMA NumberP250017
Supplement NumberS001
Date Received01/21/2026
Decision Date04/07/2026
Product Code QTL 
Advisory Committee Cardiovascular
Clinical TrialsNCT05409976
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the new enrollment post-approval study (PAS)
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