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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 NumberS002
Date Received02/18/2026
Decision Date03/06/2026
Product Code QTL 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to the delivery system tip bonding process
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