# Implanted Diaphragmatic/Phrenic Nerve Stimulator
> **Product code: GZE** · Class III — High Risk (PMA approval required, life-sustaining) · Neurology · 21 CFR 882.5830
## Classification
- **FDA Product Code:** GZE
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 882.5830
- **Review panel:** AN
- **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 7/7/86 per 51 fr 12101 on 4/8/86

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=GZE)
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