modify undesirable behavioral characteristics. (b) Classification. Class II (performance standards). § 882.5250 Burr hole cover. (a) Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. (b) Classification. Class II (performance standards). § 882.5275 Nerve cuff. (a) Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors). (b) Classification. Class II (performance standards). (a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). 8882.5330 Preformed nonalterable cranioplasty plate. (a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or re $882.5800 shaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). § 882.5360 Cranioplasty plate fastener. (a) Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect. (b) Classification. Class II (performance standards). § 882.5500 Lesion temperature monitor. (a) Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe. (b) Classification. Class II (performance standards). § 882.5550 Central nervous system fluid shunt and components. (a) Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. (b) Classification. Class II (performance standards). § 882.5800 Cranial electrotheraphy stimulator. (a) Identification. A cranial electrotheraphy stimulator is a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] § 882.5810 External functional neuromuscular stimulator. (a) Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait. (b) Classification. Class II (performance standards). § 882.5820 Implanted cerebellar stimulator. (a) Identification. An implanted cerebellar stimulator is a device used to stimulate electrically a patient's cerebellar cortex for the treatment of intractable epilepsy, spasticity, and some movement disorders. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's cerebellum and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 26, 1984. Any implanted cerebellar stimulator that was not in commercial distribution before May 28, 1976, or that has not on or before September 26, 1984 been found by FDA to be substantially equivalent to an implanted cerebellar stimulator that was in commercial distribution before May 28, 1976 shall have an approved PMA or declared completed PDP in effect before beginning commercial distribution. [44 FR 51730-51778, Sept. 4, 1979 and 49 FR 26574, June 28, 1984] phrenic nerve stimulator. (a) 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. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 7, 1986 for any implanted diaphragmatic/ phrenic nerve stimulator that was in commercial distribution before May 28, 1976, or that has on or before July 7, 1986 been found to be substantially equivalent to an implanted diaphragmatic/phrenic nerve stimulator that was in commercial distribution before May 28, 1976. Any other implanted diaphragmatic/phrenic nerve stimulator shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [44 FR 51730-51778, Sept. 4, 1979, as amended at 51 FR 12101, Apr. 8, 1986] across the patient's skin to the implanted receiver. (b) Classification. Class III (premarket approval). (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 1, 1989, for any implanted intracerebral/ subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976, or that has on or before March 1, 1989, been found to be substantially equivalent to an implanted intracerebral/subcortical stimulator for pain relief that was in commercial distribution before May 28, 1976. Any other implanted intracerebral/ subcortical stimulator for pain relief shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. [44 FR 51730-51778, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988] § 882.5850 Implanted spinal cord stimulator for bladder evacuation. (a) 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. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] § 882.5860 Implanted neuromuscular stimulator. (a) Identification. An implanted neuromuscular stimulator is a device that provides electrical stimulation to a patient's peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with electrodes that are placed around a patient's nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. The external transmitter is activated by a switch in the heel in the patient's shoe. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] § 882.5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an inplanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class II (performance standards). § 882.5880 Implanted spinal cord stimulator for pain relief. (a) Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver. (b) Classification. Class II (perform- ly obstruct blood flow to an aneurysm ance standards). or other vascular malformation. (a) Identification. An electroconvulsive therapy device is a device used for treating severe psychiatric disturbances (e.g., severe depression) by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 882.3. [44 FR 51730-51778, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] § 882.5950 Artificial embolization device. (a) Identification. An artificial embolization device is an object that is placed in a blood vessel to permanent |