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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, intracerebral/subcortical, implanted
Regulation Description Implanted intracerebral/subcortical stimulator for pain relief.
Definition Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGYZ
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5840
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible