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U.S. Department of Health and Human Services

Product Classification
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Device neuromodulator for obesity
Definition Weight reduction by peripheral neuromodulation.
Physical State Pulse generator with leads
Technical Method Neural modulation with implantable electrical pulse generators.
Target Area Enteric nervous system
Review Panel Gastroenterology/Urology
Product CodePIM
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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