NPW · Percutaneously Delivered Prostheses And Tricuspid Valves
· Class 3
Overview
| Product Code | NPW |
|---|---|
| Device Name | Percutaneously Delivered Prostheses And Tricuspid Valves |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
These devices are intended to replace a patient's tricuspid 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230013 | Edwards EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences, LLC | Feb 1, 2024 | APPR |
Top Applicants
- Edwards Lifesciences, LLC — 1 clearance
