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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGORE EXCLUDER AAA ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
W.L. GORE & ASSOCIATES,INC
32360 n. north valley parkway
phoenix, AZ 85085
PMA NumberP020004
Supplement NumberS094
Date Received04/28/2014
Decision Date05/28/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
NEW SUPPLIER FOR BIOLOGICAL INDICATORS.
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