FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse-Generator, Single Chamber, Single
PMA: P850027
·
Decision Sep 30, 1986
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
- Device Class
- FDA Class 3
- Product Code
- LWW
- Generic Name
- PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 30, 1986
- Date Received
- May 6, 1985
- Expedited Review
- N
- Docket Number
- 86M-0402
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 |