# Stimulator, Intracerebral/Subcortical, Implanted
> **Product code: GYZ** · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5840
## Classification
- **FDA Product Code:** GYZ
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 882.5840
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=GYZ)
---
*AI Analytics · CC0 1.0*