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Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

FDA product code SBA · 1 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1357
Review panel
CH
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-09-16 – 2024-09-16

An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.

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