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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name integrated continuous glucose monitoring system with sensor containing dexamethasone acetate
De Novo Number DEN230052
Device Name Eversense AP CGM System
Senseonics, Incorporated
20451 seneca meadows parkway
germantown,  MD  20876 -7005
Contact mukul jain
Regulation Number862.1357
Classification Product Code
Date Received08/09/2023
Decision Date 04/29/2024
Decision granted (DENG)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Reclassification Order Reclassification Order
Type Direct