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 Conformable TAG Thoracic Endoprosthesis
• Generic Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Applicant: W. L. GORE & ASSOCIATES, INC.; 3450 KILTIE LANE; P.O. BOX 2400; FLAGSTAFF, AZ 86003-2400
• PMA Number: P040043
• Supplement Number: S105
• Date Received: 09/21/2018
• Decision Date: 10/17/2018
• 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: No

Approval Order Statement  
Implement an additional film attach machine to be used during the manufacture of the GORE Conformable TAG Thoracic Endoprosthesis.