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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, electrical, implanted, for parkinsonian tremor
Review Panel Neurology
Product CodeMHY
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
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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