FDA.reportPublic FDA data

De Novo DEN230052

Device
Eversense AP CGM System
Contact
mukul jain
De Novo number
DEN230052
Product code
SBA
Regulation
862.1357
Classification name
integrated continuous glucose monitoring system with sensor containing dexamethasone acetate
Decision
granted (DENG)
Decision date
2024-04-29
Date received
2023-08-09
Classification advisory
Clinical Chemistry
Review advisory
Clinical Chemistry
Type
Direct

Current FDA Classification#

Product code
SBA
Device name
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Medical specialty
Clinical Chemistry
Device class
2
Regulation
862.1357
Implant
Y
Life sustain/support
N