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U.S. Department of Health and Human Services

Product Classification

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Device artificial pancreas device system, bihormonal control
Definition A bihormonal artificial pancreas system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump.Hormone adjustments are based upon specified thresholds of measured glucose levels.
Physical State May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software
Technical Method Uses a glucose monitoring system to measure glucose levels and increases or reduces two glucose modulating therapies from an insulin pump
Target Area Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software
Review Panel Clinical Chemistry
Product CodeOZQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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