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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.
 
DeviceAFX ENDOVASCULAR AAA SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
ENDOLOGIX, INC.
11 studebaker
irvine, CA 92618
PMA NumberP040002
Supplement NumberS045
Date Received12/17/2013
Decision Date02/06/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF A CONTRACT STERILIZER LOCATED AT STERIS-ISOMEDIX SERVICES, IN TEMECULA, CALIFORNIA.
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