21 CFR 882.5820 — Implanted Cerebellar Stimulator
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5820
Identification
An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification Rationale
Class III (premarket approval).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZA | Implanted Cerebellar Stimulator | 3 | 0 | Implant |
