# Stimulator, Electrical, Implantable, For Incontinence
> **Product code: EZW** · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.5270
## Classification
- **FDA Product Code:** EZW
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 876.5270
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 22
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=EZW)
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