21 CFR 882.5830 — Implanted Diaphragmatic/Phrenic Nerve Stimulator

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5830

Identification

An implanted diaphragmatic/phrenic nerve stimulator is a device that provides electrical stimulation of a patient's phrenic nerve to contract the diaphragm rhythmically and produce breathing in patients who have hypoventilation (a state in which an abnormally low amount of air enters the lungs) caused by brain stem disease, high cervical spinal cord injury, or chronic lung disease. The stimulator consists of an implanted receiver with electrodes that are placed around the patient's phrenic nerve 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