|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||OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| 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.