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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 NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP210032
Supplement NumberS020
Date Received05/13/2025
Decision Date06/11/2025
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an update to the sampling plan protection of the stent winding tensile sampling plan for the Gore TAG Thoracic Branch Endoprosthesis (Side Branch component).
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