EZW · Stimulator, Electrical, Implantable, For Incontinence
Gastroenterology, Urology · 21 CFR 876.5270 · Class 3
Overview
| Product Code | EZW |
|---|---|
| Device Name | Stimulator, Electrical, Implantable, For Incontinence |
| 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).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240031 | Neuspera Sacral Neuromodulation System | Neuspera Medical, Inc. | Jun 17, 2025 | APPR |
| P170001 | VIRTIS SACRAL NEUROMODULATION SYSTEM | Cirtec Medical Corporation | Jan 11, 2023 | APPR |
| P180046 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Nov 13, 2019 | APPR |
| P970004 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | Medtronic Neuromodulation | Sep 29, 1997 | APPR |
Top Applicants
- Boston Scientific Corporation — 1 clearance
- Cirtec Medical Corporation — 1 clearance
- Medtronic Neuromodulation — 1 clearance
- Neuspera Medical, Inc. — 1 clearance
