← Product Code [DYE](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE) · P870078

# HANCOCK PORCINE BIOPROSTHESIS (P870078)

_Medtronic, Inc. · DYE · Sep 28, 1989 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870078

## Device Facts

- **Applicant:** Medtronic, Inc.
- **Product Code:** [DYE](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE.md)
- **Decision Date:** Sep 28, 1989
- **Decision:** APPR
- **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/P870078](https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DYE/P870078)

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