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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, autonomic nerve, implanted for epilepsy
Review Panel Neurology
Product CodeLYJ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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