NPV · Pulmonary Valve Prosthesis Percutaneously Delivered
· Class f
Overview
| Product Code | NPV |
|---|---|
| Device Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Device Class | Class f |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200015S011 | Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent | Edwards Lifesciences, LLC | Dec 16, 2021 | APPR |
| P200046 | Harmony TPV System | Medtronic, Inc. | Mar 26, 2021 | APPR |
| P200015 | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | Edwards Lifesciences, LLC | Aug 31, 2020 | APPR |
| P140017S005 | MELODY TRANSCATHETER PULMONARY VALVE, ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM and ENSEMBLE II TRANSCATHETER VALVE D | Medtronic, Inc. | Feb 24, 2017 | APPR |
| P140017 | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) | Medtronic, Inc. | Jan 27, 2015 | APPR |
Top Applicants
- Medtronic, Inc. — 3 clearances
- Edwards Lifesciences, LLC — 2 clearances
