FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Implantable Pulse Generator, Pacemaker (Non-Crt)
PMA: P860027
·
Decision Feb 27, 1987
Classifications
1
FEI Numbers
35
Registration Numbers
35
Basic Information
- Device Name
- Implantable Pulse Generator, Pacemaker (Non-Crt)
- Trade Name
- MAESTRO SERIES 500 P.G. MODELS 501, 505, 509
- PMA Number
- P860027
- Device Class
- FDA Class 3
- Product Code
- LWP
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 27, 1987
- Date Received
- July 28, 1986
- Expedited Review
- N
- Docket Number
- 87M-0085
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 |
|---|---|---|---|
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | FDA class 3 | Unknown |