|Trade Name||ENDURANT IIS STENT GRAFT SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternate supplier for the secondary and tertiary packaging for endurant iis stent graft systems, as well as a change in configuration for the e-beam sterilization process.