|Trade Name||ZENITH FLEX ENDOVASCULAR GRAFT|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of manufacturing instructions to assure that the proximal trigger wire is not inadvertently attached to both trigger knobs of the delivery system.