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U.S. Department of Health and Human Services

Product Classification
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Device aspiration therapy system
Definition Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults
Physical State PEG tube made of plastic
Technical Method percutaneous implantation
Target Area stomach
Review Panel Gastroenterology/Urology
Product CodeOYF
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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