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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sensor, glucose, invasive, component of automated insulin delivery system
Definition The device is intended to measure glucose in interstitial fluid. It is intended to provide those measurements as inputs to appropriately qualified digitally connected devices, including automated insulin dosing systems, as determined by FDA.
Product CodeSFI
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 0 5

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