FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Replacement Heart-Valve
PMA: P870078
·
Decision Sep 28, 1989
Classifications
1
FEI Numbers
11
Registration Numbers
11
Basic Information
- Device Name
- Replacement Heart-Valve
- Trade Name
- HANCOCK PORCINE BIOPROSTHESIS
- PMA Number
- P870078
- Device Class
- FDA Class 3
- Product Code
- DYE
- Generic Name
- replacement Heart-valve
- Regulation Number
- 870.3925
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 28, 1989
- Date Received
- December 8, 1987
- Expedited Review
- N
- Docket Number
- 89M-0426
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYE | Replacement Heart-Valve | FDA class 3 | Cardiovascular |