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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, autonomic nerve, implanted for stroke rehabilitation
Definition Stimulation of the vagus nerve
Physical State Implantable pulse generator, implantable lead, wireless transmitter
Technical Method Uses implantable pulse generator and lead to stimulate vagus nerve
Target Area Vagus nerve
Review Panel Physical Medicine
Product CodeQPY
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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