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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 NumberS041
Date Received05/02/2013
Decision Date06/17/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM.
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