|Trade Name||TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: manufacturer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing site located at medtronic cardiac surgery, medtronic perfusion systems, minneapolis, minnesota. The proposed site will be performing rework of packaging and labeling.