EZT · Pacemaker, Bladder
Gastroenterology, Urology · 21 CFR 876.5270 · Class 3
Overview
| Product Code | EZT |
|---|---|
| Device Name | Pacemaker, Bladder |
| Regulation | 21 CFR 876.5270 |
| Device Class | Class 3 |
| Review Panel | Gastroenterology, Urology |
| 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).
Cleared Devices (0)
No cleared devices on record.
