DevicePMAs@therightstef:P060038_S026 JSONTXT

Approval for minor design modifications to the mitroflow aortic pericardial heart valve model dl, namely the addition of radiographic markers on the sewing ring and addition of visible markers on the sewing cuff. the device, as modified, will be marketed under the trade name crown prt aortic pericardial heart valve with pr treatment and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.