← Product Code [DYE](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE) · P870077

# CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077)

_Edwards Lifesciences, LLC · DYE · Sep 25, 1991 · Cardiovascular · APWD_

**Canonical URL:** https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870077

## Device Facts

- **Applicant:** Edwards Lifesciences, LLC
- **Product Code:** [DYE](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE.md)
- **Decision Date:** Sep 25, 1991
- **Decision:** APWD
- **Regulation:** 21 CFR 870.3925
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870077](https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870077)

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