|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 AAA ENDOVASCULAR GRAFT|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the instructions for use (ifu) labeling. The labeling changes involved recommendations to users regarding maintaining hemostasis, use of fluoroscopy and trigger wire release, and an alternative suprarenal deployment sequence.