FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Neuromuscular, Implanted
PMA: P950035
·
Supplement: S005
·
Decision Jan 13, 2000
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Stimulator, Neuromuscular, Implanted
- Trade Name
- NEUROCONTROL FREEHAND SYSTEM
- PMA Number
- P950035
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- GZC
- Generic Name
- Stimulator, neuromuscular, implanted
- Regulation Number
- 882.5860
- Medical Specialty
- Neurology
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 13, 2000
- Date Received
- November 24, 1999
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
1)Replace the MRI warning in the package insert,clinician manual and user manual with a precaution statement that provides information for performing MRI scanning of patients with the Freehand System; 2) modify the IDE card to include wording advising NeuroControl be contacted for information prior to MRI scanning; 3) "MRI Information Sheet" which provides guidance for MRI scanning will be provided upon request.
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 |
|---|---|---|---|
| GZC | Stimulator, Neuromuscular, Implanted | FDA class 3 | Neurology |