HANCOCK PORCINE BIOPROSTHESIS
Device Facts
| Record ID | P870078 |
|---|---|
| Device Name | HANCOCK PORCINE BIOPROSTHESIS |
| Applicant | Medtronic, Inc. |
| Product Code | DYE · Cardiovascular |
| Decision Date | Sep 28, 1989 |
| Decision | APPR |
| Regulation | 21 CFR 870.3925 |
| Device Class | Class 3 |
Regulatory Classification
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.
