QON · Implanted Electrical Device Intended For Treatment Of Fecal Incontinence
Gastroenterology, Urology · 21 CFR 876.5270 · Class 3
Overview
| Product Code | QON |
|---|---|
| Device Name | Implanted Electrical Device Intended For Treatment Of Fecal 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P190006 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Sep 6, 2019 | APPR |
| P080025 | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | Medtronic Neuromodulation | Mar 14, 2011 | APPR |
Top Applicants
- Boston Scientific Corporation — 1 clearance
- Medtronic Neuromodulation — 1 clearance
