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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
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS061
Date Received07/10/2018
Decision Date08/09/2018
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modifications to the AFX System Instructions for Use, specifically the inclusion of a sizing algorithm and clarification on device sizing guidelines.