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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
PMA NumberP100021
Supplement NumberS039
Date Received07/25/2014
Decision Date10/23/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of five (5) short bifurcated stent graft configurations to the endurant ii stent graft system, which are called endurant iis stent grafts (also referred to as endurant iis). The device, as modified, will be marketed under the trade name endurant iis stent graft system. The endurant ii/endurant iis bifurcated stent grafts are 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 bifurcated stent graft. The endurant ii/endurant iis 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 >=10 mm; 3) infrarenal neck angulation <=60°; 4) aortic neck diameters with a range of 19 to 32 mm; 5) distal fixation lengths >=15 mm; 6) iliac diameters with a range of 8 to 25 mm; and 7) morphology suitable for aneurysm repair.