21 CFR 882.5850 — Stimulator, Spinal-Cord, Implanted, For Bladder Evacuation

Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5850

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).

Product Codes