GYZ · Stimulator, Intracerebral/Subcortical, Implanted
Neurology · 21 CFR 882.5840 · Class 3
Overview
| Product Code | GYZ |
|---|---|
| Device Name | Stimulator, Intracerebral/Subcortical, Implanted |
| Regulation | 21 CFR 882.5840 |
| Device Class | Class 3 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
An implanted intracerebral/subcortical stimulator for pain relief is a device that applies electrical current to subsurface areas of a patient's brain to treat severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed within a patient's brain 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.
