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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 | S040 |
Date Received | 07/01/2011 |
Decision Date | 01/13/2012 |
Product Code |
MIH |
Docket Number | 12M-0056 |
Notice Date | 01/19/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00917852
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Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ISOLATED LESIONS (NOT INCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA, IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING ADEQUATE ILIAC/FEMORAL ACCESS, AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM, AND >= 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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