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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 NumberS020
Date Received11/06/2007
Decision Date12/06/2007
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADOPTION OF AN ELECTRONIC VERIFICATION SYSTEM (EVS) TO BE USED IN THE PACKAGING OF THE DEVICE.
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