Stimulator, Neuromuscular, Implanted
Basic Information
- Device Name
- Stimulator, Neuromuscular, Implanted
- Trade Name
- NEUROCONTROL FREEHAND SYSTEM
- PMA Number
- P950035
- Supplement Number
- S004
- 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
- May 18, 1999
- Date Received
- April 7, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for the following: 1) Changing the manufacturing site for the Epimysial Probe, Anode Plate, and Epimysial Electrode to Lewicki Microelectronic, GmbH; 2) Changing the site for packaging and sterilization of the Freehand System Electrode Positioning Kit and Epimysial Electrode to Lewicki Microelectronic , GmbH; 3) Addition of two paper measuring tapes to the Electrode Positioning Kit; 4) Changing the materila used to support the Anode Plate and the coating over this material; 5) Changing the material used to coat the weld of the Epimysial Electrode; 6) Changing the vendor for the connector pin, strain relief springs, and center springs of the Implantable Connector of the Epimysial Electrode; 7) Changing the manufacturing procedures, packaging, and sterlization process; and 8) Changing the labeling to include symbols that conform to European CE Marketing requirements.
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 |