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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
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS054
Date Received05/19/2015
Decision Date06/17/2015
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
Approval Order Statement  
APPROVAL FOR UPDATES TO THE AFX INSTRUCTIONS FOR USE TO CLARIFY EXISTINGINFORMATION RELATED TO PROCEDURE PLANNING AND FOLLOW-UP IMAGING, AND TO IMPROVE THE INSTRUCTIONS FOR DELIVERY SYSTEM WITHDRAWAL OF THE AFX VELA PROXIMAL ENDOGRAFT.
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