21 CFR 882.5840 — Stimulator, Intracerebral/Subcortical, Implanted

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5840

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).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GYZStimulator, Intracerebral/Subcortical, Implanted30Implant
Innolitics

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