|Trade Name||ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Generic Name||endovascular grafting system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the training program to allow less than 100% case support at centers that meet the established criteria. This change affects the conditions of approval described in the original approval order, dated suptember 28, 1999.