|Trade Name||ANCURE ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Generic Name||endovascular grafting system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the five year follow-up protocol: a) changing the follow-up schedule; b) removing the ultrasound and ankle brachial indices (abi) assessments; c) replacing the annual physical exam for control patients with an annual telephone survey and computed tomography (ct) and physical exam at the five year mark; d) allowing an optional telephone survey for patients unable or unwilling to come to the investigational site; and e) excluding patients who have been converted from further study follow-up.