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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 NumberP120006
Supplement NumberS001
Date Received10/24/2012
Decision Date12/11/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the endovascular system, mainly the delivery system, to improve the ease-of-use during deployment. The device, as modified, will be marketed under the trade name ovation prime abdominal stent graft system and is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: 1) adequate iliac/femoral access compatible with vascular access techniques, devices and/or accessories; 2) non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm, b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and c) with an aortic angle of <= 60 degree if proximal neck is >= 10 mm and <= 45 degrees if proximal neck is <= 10 mm. 3) adequate distal iliac landing zone: a) with a length of at least 10 mm, and b) with an inner wall diameter of no less then 8 mm and no greater than 20 mm.