← Product Code [EZW](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW) · P970004

# MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL (P970004)

_Medtronic Neuromodulation · EZW · Sep 29, 1997 · Gastroenterology, Urology · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-f%E2%80%94therapeutic-devices/EZW/P970004

## Device Facts

- **Applicant:** Medtronic Neuromodulation
- **Product Code:** [EZW](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EZW.md)
- **Decision Date:** Sep 29, 1997
- **Decision:** APPR
- **Regulation:** 21 CFR 876.5270
- **Device Class:** Class 3
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Expedited Review

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-f%E2%80%94therapeutic-devices/EZW/P970004](https://fda.innolitics.com/submissions/GASTROENTEROLOGY%2C%20UROLOGY/subpart-f%E2%80%94therapeutic-devices/EZW/P970004)

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