FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse-Generator, Single Chamber, Single
PMA: P850027
·
Supplement: S005
·
Decision Feb 2, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Single
- Trade Name
- TELECTRONICS PASAR MODEL 4171 PG
- PMA Number
- P850027
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LWW
- Generic Name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 2, 1990
- Date Received
- January 16, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Other
- Expedited Review
- N
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 |
|---|---|---|---|
| LWW | Pulse-Generator, Single Chamber, Single | FDA class 3 | Unknown |