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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 NumberS043
Date Received03/13/2024
Decision Date04/02/2024
Product Codes PRL QZK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling update to reflect the use of GORE VIABAHN VBX Balloon Expandable Endoprosthesis with thoracoabdominal and pararenal branched devices that are indicated with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component
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