DevicePMAs@therightstef:P110032_S000 JSONTXT 11 Projects

Approval for the aorfix aaa flexible stent graft system. this device is indicated for the treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascularrepair, including: 1) adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories; 2) aortic neck landing zone diameters with a range of 19mm to 29mm; 3) non aneurysmal proximal neck center-line length of >= l5mm; 4) lnfrarenal aortic neck angulations including those up to and including 90; 5) common iliac landing zone diameters with a range of 9mm to 19mm; and 6) distal fixation length of >= 15mm.