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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGORE TAG THORACIC ENDOPROSTHESIS
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantW. L. GORE & ASSOCIATES, INC.
3450 KILTIE LANE
P.O. BOX 2400
FLAGSTAFF, AZ 86003-2400
PMA NumberP040043
Supplement NumberS051
Date Received03/14/2013
Decision Date09/10/2013
Product Code MIH 
Docket Number 13M-1323
Notice Date 10/24/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00908388
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE GORE TAG THORACIC ENDOPROSTHESIS. THIS DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA, INCLUDING:1) ISOLATED LESIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) AORTIC INNER DIAMETER IN THE RANGE OF 16-42 MM; AND C) > 20 MM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE LESION.2) TYPE B DISSECTIONS IN PATIENTS WHO HAVE APPROPRIATE ANATOMY, INCLUDING:A) ADEQUATE ILIAC I FEMORAL ACCESS;B) > 20 MM LANDING ZONE PROXIMAL TO THE PRIMARY ENTRY TEAR; PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED; ANDC) DIAMETER AT PROXIMAL EXTENT OF PROXIMAL LANDING ZONE IN THE RANGE OF 16-42 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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