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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.
 
DeviceReduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis (RP VBX Device)
Generic NameIliac covered stent, arterial
ApplicantW. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP160021
Supplement NumberS047
Date Received11/22/2024
Decision Date05/20/2025
Product Code PRL 
Advisory Committee Cardiovascular
Clinical TrialsNCT03728985
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
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