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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 TAG Thoracic Branch Endoprosthesis (TBE Device)
ApplicantW. L. Gore & Associates, Inc.
3450 West Kiltie Lane
Flagstaff, AZ 86005
PMA NumberP210032
Supplement NumberS007
Date Received02/07/2023
Decision Date05/02/2023
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT02777593
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for an expansion of the indications for use and modifications to the Instructions for Use of the Gore TAG Thoracic Branch Endoprosthesis (TBE Device).