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U.S. Department of Health and Human Services

Product Classification
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Device vagus nerve stimulator for rheumatoid arthritis
Definition Implantable vagus nerve stimulator for Rheumatoid Arthritis
Physical State Small implanted stimulator module directly placed in contact with the vagus nerve surface, and a wireless charging/programming unit that externally communicates with the implanted component. Software application also used to configure the wireless charger/programmer
Technical Method Applies electrical stimulation to the vagus nerve in order to activate an immune system reflex and stop inflammatory processes
Target Area On the vagus nerve in the neck, and the external neck surface for charger/programming component
Review Panel Neurology
Product CodeSFJ
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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