|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|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a quality control step verifying the orientation of the converter while it is being loaded into the delivery catheter.