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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 ENDOPROSATHESIS WITH C3 DELIVERY SYSTEM
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 NumberS085
Date Received07/16/2013
Decision Date08/26/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REDUCING THE SIZE OF THE SECOND DEPLOYMENT LINE SLIP KNOT LOOP AND A NEW DEPLOYMENT TEST FIXTURE INSERT.
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