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U.S. Department of Health and Human Services

Product Classification
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Device gastrointestinal liner system
Definition for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.
Physical State Grasper and Retrieval Hood
Technical Method It is provided sterile and consists of a gastrointestinal liner (anchor and liner), preloaded in a catheter that delivers the liner to the proximal intestine.
Target Area GI
Review Panel Gastroenterology/Urology
Product CodePFE
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
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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