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