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 ENDOPROSTHESIS
• Generic Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Applicant: W. L. Gore & Associates, Inc.; 3450 Kiltie Ln.; P.O. Box 2400; Flagstaff, AZ 86003
• PMA Number: P040043
• Supplement Number: S069
• Date Received: 09/29/2014
• Decision Date: 10/29/2014
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
IMPLEMENTATION OF AN ALTERNATE GORE FACILITY TO CONDUCT CYTOTOXICITY TESTING AND A NEW TUBE READER FOR LAL BACTERIAL ENDOTOXIN TESTING.