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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 NumberS045
Date Received02/07/2012
Decision Date03/16/2012
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 AN ALTERNATE FLUORINATED ETHYLENE PROPYLENE (FEP) RESIN AND AN ALTERNATE SUPPLIER FOR THE FEP FILM. THE SUPPLEMENT ALSO REQUESTED APPROVAL FOR A CHANGE TO THE SPECIFICATIONS OF THE FEP FILM. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME IDENTIFIED.
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