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U.S. Department of Health and Human Services

Product Classification

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Device implanted cerebellar stimulator
Regulation Description Implanted cerebellar stimulator.
Definition Call for pmas 9/26/84 per 49 fr 26574 on 6/28/84
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZA
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Regulation Number 882.5820
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