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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 NumberS010
Date Received05/18/2006
Decision Date06/16/2006
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the procedures employed in the labeling of the gore tag thoracic endoprosthesis. These modifications are intended to enhance the safe use of the device by minimizing the potential for mislabeling of devices.
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