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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGORE TAG THORACIC ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW. L. GORE & ASSOCIATES, INC.
PMA NumberP040043
Supplement NumberS067
Date Received07/18/2014
Decision Date10/21/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Clinical Trials NCT00590759
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an update to the labeling for the gore tag thoracic endoprosthesis to reflect the findings of the post-approval study.
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