21 CFR 876.5270 — Pacemaker, Bladder
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5270
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EZT | Pacemaker, Bladder | 3 | 0 | Implant |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | 3 | 4 | Implant |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | 3 | 2 | Implant |
