FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Heart-Valve, Mechanical
PMA: P850006
·
Decision Aug 29, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Heart-Valve, Mechanical
- Trade Name
- DUROMEDICS BILEAFLET HEART VALVE
- PMA Number
- P850006
- Device Class
- FDA Class 3
- Product Code
- LWQ
- Generic Name
- HEART-VALVE, MECHANICAL
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- August 29, 1986
- Date Received
- February 4, 1985
- Expedited Review
- N
- Docket Number
- 86M-0377
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 |
|---|---|---|---|
| LWQ | Heart-Valve, Mechanical | FDA class 3 | Unknown |