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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 NumberS011
Date Received11/02/2011
Decision Date04/27/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified version of the endurant stent graft system. The endurant ii stent graft system is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms having adequate iliac/femoral access that is compatible with vascular access techniques, devices and/or accessories; proximal neck length of => 10 mm: infrarenal neck angulation of =< 60°; distal fixation length of => 15 mm; aortic neck diameters with a range of 19-32 mm; iliac diameters with a range of 8-25 mm and morphology suitable for aneurysm repair.