MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
Device Facts
| Record ID | P970004 |
|---|---|
| Device Name | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL |
| Applicant | Medtronic Neuromodulation |
| Product Code | EZW · Gastroenterology, Urology |
| Decision Date | Sep 29, 1997 |
| Decision | APPR |
| Regulation | 21 CFR 876.5270 |
| Device Class | Class 3 |
| Attributes | Expedited Review |
Regulatory Classification
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.
