# NPU · Prosthesis, Mitral Valve, Percutaneously Delivered

_ ·  · Class 3_

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

## Overview

- **Product Code:** NPU
- **Device Name:** Prosthesis, Mitral Valve, Percutaneously Delivered
- **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 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](https://fda.innolitics.com/submissions/CV/CV-misc/NPU/P250019.md) | SAPIEN M3 Transcatheter Mitral Valve Replacement System | Edwards Lifesciences, LLC | Dec 22, 2025 | APPR |
| [P240042](https://fda.innolitics.com/submissions/CV/CV-misc/NPU/P240042.md) | Tendyne Transcatheter Mitral Valve System | ABBOTT MEDICAL | May 23, 2025 | APPR |

## Top Applicants

- ABBOTT MEDICAL — 1 clearance
- Edwards Lifesciences, LLC — 1 clearance

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

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