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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, brain, implanted, for behavior modification
Review Panel Neurology
Product CodeMFR
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
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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