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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.
 
DeviceGORE EXCLUDER AAA ENDOPROSTHESIS
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie lane
p.o. box 2400
flagstaff, AZ 86003-2400
PMA NumberP020004
Supplement NumberS092
Date Received03/25/2014
Decision Date06/20/2014
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 delivery system profile reduction (23, 26mm devicesreduced from 18f to 16f), sleeve construct modifications, and delivery catheter modifications.
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