GZD · Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation
Neurology · 21 CFR 882.5850 · Class 3
Overview
| Product Code | GZD |
|---|---|
| Device Name | Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation |
| Regulation | 21 CFR 882.5850 |
| Device Class | Class 3 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted spinal cord stimulator for bladder evacuation is an electrical stimulator used to empty the bladder of a paraplegic patient who has a complete transection of the spinal cord and who is unable to empty his or her bladder by reflex means or by the intermittent use of catheters. The stimulator consists of an implanted receiver with electrodes that are placed on the conus medullaris portion of the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
