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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)
Generic NameEndovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP210032
Supplement NumberS015
Date Received08/26/2024
Decision Date04/11/2025
Product Code SDZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT02777528
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  
Approval for the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) for expanding the indications to include treatment of lesions of the aortic arch. This device is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel, in patients with appropriate anatomy.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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