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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 NumberS024
Date Received08/20/2008
Decision Date11/07/2008
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DISTAL END OF THE DELIVERY SYSTEM WHERE THE ENDOGRAFT IS CONSTRAINED AND CHANGES TO THE DELIVERY CATHETER HUB, AND IS INDICATED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY.
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