Prosthesis, Mitral Valve, Percutaneously Delivered

FDA product code NPU · Class III (high risk) · Cardiovascular

These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.

0510(k) clearances
2PMA approvals
0recalls
Implantimplanted device

PMA approvals