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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.
 
DeviceGODRE TAG THORACIC ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 kiltie lane
p.o. box 2400
flagstaff, AZ 86003-2400
PMA NumberP040043
Supplement NumberS060
Date Received01/14/2014
Decision Date06/04/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE DESTRUCTIVE TESTING SAMPLING PLAN AND CHANGE IN THE DEPLOYMENT FORCE SPECIFICATION.
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