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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 ENDOPROSTESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040043
Supplement NumberS037
Date Received09/02/2010
Decision Date02/24/2011
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the gore tag thoracic endoprosthesis instructions for use to include summary information on the evaluation of the physician training program for this device.
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