Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3925](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3925) → PAL — Pulmonic Replacement Heart Valve

# PAL · Pulmonic Replacement Heart Valve

_Cardiovascular · 21 CFR 870.3925 · Class f_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAL

## Overview

- **Product Code:** PAL
- **Device Name:** Pulmonic Replacement Heart Valve
- **Regulation:** [21 CFR 870.3925](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3925)
- **Device Class:** f
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes
- **Life-sustaining:** yes

## Identification

A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAL](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/PAL)

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