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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 NumberS050
Date Received03/12/2010
Decision Date05/12/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the removal of the center knot sleeve attachment.
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