DevicePMAs@therightstef:P060038_S017 JSONTXT

Approval for manufacturing process changes to the mitroflow aortic pericardial heart valve, model lx, consisting of implementation of the phospholipid reduction treatment manufacturing process (an anticalcification treatment process). the device, as modified, will be marketed under the trade name mitroflow aortic pericardial heart valve with phospholipid reduction treatment, model dl and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.