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U.S. Department of Health and Human Services

Product Classification

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Device implant, intragastric for morbid obesity
Review Panel Gastroenterology/Urology
Product CodeLTI
Premarket Review Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors (OHT3)
Gastroenterology, Renal, Endoscopy, Transplant and Obesity Devices (DHT3A)
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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