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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 NumberS025
Date Received09/03/2008
Decision Date10/03/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an automated film wrapping machine for the excluder wrapped grafts and cuffs and tag wrapped cuff.
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