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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 STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
2 Musick
Irvine, CA 92618
PMA NumberP040002
Supplement NumberS038
Date Received07/05/2012
Decision Date08/22/2012
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR STAND-ALONE DELIVERY SYSTEM FOR THE STRAIGHT AND TAPERED LIMB EXTENSION STENT GRAFTS AND FOR THE FLARED LIMB EXTENSIONS GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM AS AN ACCESSORY TO THE AFX AAA ENDOVASCULAR SYSTEM WHICH IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.
Post-Approval StudyShow Report Schedule and Study Progress
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