NPU · Prosthesis, Mitral Valve, Percutaneously Delivered
· Class 3
Overview
| Product Code | NPU |
|---|---|
| Device Name | Prosthesis, Mitral Valve, Percutaneously Delivered |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P250019 | SAPIEN M3 Transcatheter Mitral Valve Replacement System | Edwards Lifesciences, LLC | Dec 22, 2025 | APPR |
| P240042 | Tendyne Transcatheter Mitral Valve System | ABBOTT MEDICAL | May 23, 2025 | APPR |
Top Applicants
- ABBOTT MEDICAL — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance
