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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, electrical, implanted, for parkinsonian symptoms
Definition Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.
Review Panel Neurology
Product CodeNHL
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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