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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® VBX Balloon Expandable Endoprosthesis
Generic NameIliac covered stent, arterial
ApplicantW. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP160021
Supplement NumberS051
Date Received02/06/2026
Decision Date10/08/2026
Product Code PRL 
Advisory Committee Cardiovascular
Clinical TrialsNCT05143138
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
expanding the indications to include use as a bridging stent to maintain visceral artery perfusion in fenestrated and branched endovascular aortic aneurysm repair (FEVAR and BEVAR)
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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