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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 NumberS009
Date Received11/12/2013
Decision Date04/23/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the indication for use for the ovation and ovation prime abdominal stent graft systems by clarifying that percutaneous access and femoral cutdown are appropriate vascular access techniques. The device, the trivascular ovation and ovation prime abdominal stent graft system, 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 (femoral cutdown or percutaneous), devices, and/or accessories; 2) proximal aortic landing zone: a) with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery; and b) with an aortic angle of =< 60 degrees if proximal neck is => 10 mm and =<45 degrees if proximal neck is <10 mm; and 3) distal iliac landing zone: a) with a length of at least 10 mm; and b) with an inner wall diameter of no less than 8 mm and no greater than 20 mm.