Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5820](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5820) → GZA — Implanted Cerebellar Stimulator

# GZA · Implanted Cerebellar Stimulator

_Neurology · 21 CFR 882.5820 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZA

## Overview

- **Product Code:** GZA
- **Device Name:** Implanted Cerebellar Stimulator
- **Regulation:** [21 CFR 882.5820](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5820)
- **Device Class:** 3
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## 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).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZA](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZA)

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