DevicePMAs@therightstef:P970031_S011 JSONTXT 11 Projects

Approval for the freestyle aortic root bioprosthesis, model 995, size 29 mm; implantation techniques, subcoronary, full-root, and root inclusion. The supplement requested approval of this size as an addition to the existing, approved product line of sizes 19, 21, 23, 25, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthestic aortic valves with the option of aortic root replacement.