|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ZENITH FLEX AAA ENDOVASCULAR GRAFT|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for use of the new z-trak introduction system with the zenith flex aaa endovascular graft, to modify the iliac leg component of the zenith flex aaa endovascular graft, and to change the packaging for the main body and iliac leg grafts.