DYE · Replacement Heart-Valve
Cardiovascular · 21 CFR 870.3925 · Class 3
Overview
| Product Code | DYE |
|---|---|
| Device Name | Replacement Heart-Valve |
| Regulation | 21 CFR 870.3925 |
| Device Class | Class 3 |
| Review Panel | Cardiovascular |
| Implant | 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P010041 | CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) | Edwards Lifesciences, LLC | Jun 24, 2002 | APWD |
| P000007 | EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P | Edwards Lifesciences, LLC | Feb 27, 2001 | APWD |
| P990064 | MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE | Medtronic, Inc. | Jul 14, 2000 | APPR |
| P980043 | HANCOCK II PORCINE BIOPROSTHESIS | Medtronic, Inc. | Sep 28, 1999 | APPR |
| P860057 | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES | Edwards Lifesciences, LLC | Sep 26, 1991 | APPR |
| P870077 | CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS | Edwards Lifesciences, LLC | Sep 25, 1991 | APWD |
| P870056 | CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 | Edwards Lifesciences, LLC | Sep 25, 1991 | APWD |
| P870078 | HANCOCK PORCINE BIOPROSTHESIS | Medtronic, Inc. | Sep 28, 1989 | APPR |
Top Applicants
- Edwards Lifesciences, LLC — 5 clearances
- Medtronic, Inc. — 3 clearances
