C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 882—NEUROLOGICAL DEVICES › Subpart F—Neurological Therapeutic Devices

21 C.F.R. § 882.5880

Implanted spinal cord stimulator for pain relief

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(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 (performance standards).

Notes of Decisions
Cited in 2 cases, 2009–2010 · leading case: Sanders v. Advanced Neuromodulation Sys., Inc., 44 So. 3d 960 (Miss. 2010).
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Sanders v. Advanced Neuromodulation Sys., Inc., 44 So. 3d 960 (Miss. 2010). · cites it 6× “Relevant to the present cause of action, 21 C.F.R. § 882.5880 classifies an “implanted spinal cord stimulator for pain relief’ as a class II device.”
William Sanders v. Advanced Neuromodulation Sys., Inc. (Miss. 2009). · cites it 5× “See 21 C.F.R. § 882.5880 (2010). The regulation states: (a) Identification.”
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