DevicePMAs@therightstef:P120006_S000 JSONTXT 11 Projects

Approval for the ovation abdominal stent graft system. this device is indicated for treatment of patients with abdominalaortic aneurysms having 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. 3) adequate distal iliac landing zone: a) with a length of at least 10 mm; and with an inner wall diameter of no less than 8 mm and no greater than 20 mm.