|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||TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM|
|Classification Name||system, endovascular graft, aortic aneurysm treatment|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the stopcock value, which is being replaced by the california valve, and the new supplier for the valve. 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 degrees if proximal neck is >= 10 mm and <= 45 degrees if proximal neck is < 10 mm; and 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 than 8 mm and no greater than 20 mm.