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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, subcortical, implanted for epilepsy
Review Panel Neurology
Product CodeLYI
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type Contact ODE
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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