FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Ventricular (Assist) Bypass
PMA: P920014
·
Decision Sep 30, 1994
Classifications
1
FEI Numbers
21
Registration Numbers
21
Basic Information
- Device Name
- Ventricular (Assist) Bypass
- Trade Name
- HEARTMATE VE LVAS
- PMA Number
- P920014
- 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- Approved (Withdrawn)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
- September 30, 1994
- Date Received
- March 30, 1992
- Expedited Review
- N
- Docket Number
- 94M-0404
Advisory Committee Statement
APPROVAL FOR THE HEARTMATE (R) IP LVAS
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 |