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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, electrical, implanted, for essential tremor
Definition Deep Brain Stimulation for the treatment of essential tremor
Physical State System components include implantable pulse generator, leads, extensions, patient programmer, and charger
Technical Method Implantable pulse generator will produce electrical pulses which will stimulate deep brain structures through electrodes on leads.
Target Area Deep Brain Structures
Review Panel Neurology
Product CodePJS
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible