Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5270](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5270) → EZT — Pacemaker, Bladder

# EZT · Pacemaker, Bladder

_Gastroenterology, Urology · 21 CFR 876.5270 · Class 3_

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

## Overview

- **Product Code:** EZT
- **Device Name:** Pacemaker, Bladder
- **Regulation:** [21 CFR 876.5270](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5270)
- **Device Class:** 3
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **Implant:** yes

## Identification

An implanted electrical urinary device is a device intended for treatment of urinary incontinence that consists of a receiver implanted in the abdomen with electrodes for pulsed-stimulation that are implanted either in the bladder wall or in the pelvic floor, and a battery-powered transmitter outside the body.

## 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/GU/subpart-f%E2%80%94therapeutic-devices/EZT](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZT)

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