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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 EXCLUDER AAA ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft
ApplicantW. L. GORE & ASSOCIATES, INC.
PMA NumberP020004
Supplement NumberS080
Date Received11/29/2012
Decision Date12/21/2012
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 
Use an alternate raw material in the graft tube components of the excluder device.
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