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U.S. Department of Health and Human Services

Product Classification
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Device implanted brain stimulator for epilepsy
Definition For the treatment of epilepsy.
Physical State The main components of the device include implanted leads (depth and cortical), implanted neurostimulator, and external programmers.
Technical Method Uses an implanted neurostimulator to sense ECoG activity and provide stimulation to depth and/or cortical leads.
Target Area seizure focii in the brain
Review Panel Neurology
Product CodePFN
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine 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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