# NPV · Pulmonary Valve Prosthesis Percutaneously Delivered

_ ·  · Class f_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/CV-misc/NPV

## Overview

- **Product Code:** NPV
- **Device Name:** Pulmonary Valve Prosthesis Percutaneously Delivered
- **Regulation:** 21 CFR N/A
- **Device Class:** f
- **Review Panel:** [](/submissions/)
- **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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P200046](https://fda.innolitics.com/submissions/CV/CV-misc/NPV/P200046.md) | Harmony™ TPV System | Medtronic, Inc. | Mar 26, 2021 | APPR |
| [P200015](https://fda.innolitics.com/submissions/CV/CV-misc/NPV/P200015.md) | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | Edwards Lifesciences, LLC | Aug 31, 2020 | APPR |
| [P140017](https://fda.innolitics.com/submissions/CV/CV-misc/NPV/P140017.md) | MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) | Medtronic, Inc. | Jan 27, 2015 | APPR |

## Top Applicants

- Medtronic, Inc. — 2 clearances
- Edwards Lifesciences, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/CV-misc/NPV](https://fda.innolitics.com/submissions/CV/CV-misc/NPV)

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