FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P900023
·
Decision Nov 20, 1992
Classifications
1
FEI Numbers
21
Registration Numbers
21
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
- PMA Number
- P900023
- Device Class
- FDA Class 3
- Product Code
- DSQ
- Generic Name
- Ventricular (assist) bypass
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- November 20, 1992
- Date Received
- April 6, 1990
- Expedited Review
- N
- Docket Number
- 92M-0477
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 |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | FDA class 3 | Unknown |