FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Monitor, Intracranial Pressure, Implanted
PMA: P820012
·
Supplement: S005
·
Decision Sep 19, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Monitor, Intracranial Pressure, Implanted
- Trade Name
- COSMAN ICP TELE-SENSOR(R)
- PMA Number
- P820012
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LII
- Generic Name
- Monitor, intracranial pressure, implanted
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 19, 1984
- Date Received
- August 9, 1984
- 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 |
|---|---|---|---|
| LII | Monitor, Intracranial Pressure, Implanted | FDA class 3 | Unknown |