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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 Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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