Premarket Approval (PMA)

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.

• Device: GORE® TAG® Thoracic Branch Endoprosthesis (TBE)
• Generic Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Applicant: W. L. Gore & Associates, Inc.; 3450 W. Kiltie Ln.; Flagstaff, AZ 86005
• PMA Number: P210032
• Supplement Number: S004
• Date Received: 09/06/2022
• Decision Date: 10/05/2022
• Product Code: MIH
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implementation of changes to the lot acceptance sampling plan requirements for components that support the sealing cuff of the endoprosthesis.