# NPW · Percutaneously Delivered Prostheses And Tricuspid Valves

_ ·  · Class 3_

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

## Overview

- **Product Code:** NPW
- **Device Name:** Percutaneously Delivered Prostheses And Tricuspid Valves
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **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](https://fda.innolitics.com/submissions/CV/CV-misc/NPW/P230013.md) | Edwards EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences, LLC | Feb 1, 2024 | APPR |

## Top Applicants

- Edwards Lifesciences, LLC — 1 clearance

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

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