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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 Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation 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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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