|
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 | S096 |
Date Received | 10/02/2017 |
Decision Date | 10/31/2017 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the Gore CTAG Thoracic Endoprosthesis Instructions for Use (IFU), including additional language in the Warnings and Precautions and Patient Counseling sections. |