|Trade Name||AFX ENDOVASCULAR AAA SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Generic Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of bifurcated stent graft models for the approved afx endovascular aaa system product family. The new models contain shorter and longer bifurcated bodies that will have the same diameter as those currently approved; and to add 20mm diameter limbs using the same stent cage.