FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Pulse-Generator, Single Chamber, Sensor Driven, Implantable
PMA: P850051
·
Supplement: S005
·
Decision Sep 10, 1986
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Pulse-Generator, Single Chamber, Sensor Driven, Implantable
- Trade Name
- ACTIVITRAX MODELS 8400, 8402, 8403
- PMA Number
- P850051
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LWO
- Generic Name
- Pulse-generator, single chamber, sensor driven, implantable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 10, 1986
- Date Received
- August 21, 1986
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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 |
|---|---|---|---|
| LWO | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | FDA class 3 | Unknown |