DevicePMAs@therightstef:P990046_S005 JSONTXT 11 Projects

Approval to combine the ats open pivot bileaflet heart valve (approved on october 13, 2000 under p990046) with the meadox hemashield woven double velour vascular graft (approved on may 11, 1993 under p840029/s005). The device, as modified, will be marketed under the trade name ats open pivot bileaflet aortic valved graft, models 502ag21 through 502ag29, and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.