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U.S. Department of Health and Human Services

Product Classification
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Device deep brain stimulation for the treatment of dystonia
Definition To stimulate deep brain structure to manage dystonia symptoms
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 CodeSGS
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Device Class 3
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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