FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Catheter, Electrode Recording, Or Probe, Electrode Recording
PMA: P950005
·
Supplement: S006
·
Decision Feb 1, 2000
Classifications
1
FEI Numbers
86
Registration Numbers
86
Basic Information
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Trade Name
- CELLSIUS INTERFACE CABLES (AUTOCLAVABLE)
- PMA Number
- P950005
- Supplement Number
- S006
- Device Class
- FDA Class 2
- Product Code
- DRF
- Generic Name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 1, 2000
- Date Received
- August 2, 1999
- 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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |