|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ENDURANT II AUI STENT GRAFT SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the endurant ii aorto-uni-iliac (aui) stent graft system, a line extension to the current endurant ii stent graft system. The device, as modified, will be marketed under the trade name endurant ii stent graft system. The endurant ii bifurcated stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. The endurant ii aorto-uni-iliac (aui) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The endurant ii stent graft system is indicated for use in patients with the following characteristics: 1) adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories; 2) proximal neck length of ¿ 10mm; 3)infrarenal neck angulation of ¿ 60°; 4) aortic neck diameters with a range of 19 to 32mm; 5) distal fixation length(s) of ¿ 15 mm; 6) iliac diameters with a range of 8 to 25mm; and 7) morphology suitable for aneurysm repair.