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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
Definition To relieve pain in patients with diabetic neuropathy
Physical State Pulse generator, leads, accessories, software
Technical Method An implantable pulse generator provides electrical stimulation to the spinal cord using implanted leads, resulting in pain relief
Target Area Spinal cord
Review Panel Neurology
Product CodeQRB
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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