PMA P160048S021

Device: Eversense® E3 Continuous Glucose Monitoring (CGM) System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S021
Product code: QHJ
Decision date: 2023-03-29
Classification: Clinical Chemistry
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval for the Eversense® E3 Continuous Glucose Monitoring System for modifying the device to reduce the frequency of calibration.

Current openFDA PMA Record#

Device: Eversense® E3 Continuous Glucose Monitoring (CGM) System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S021
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2023-03-29
Decision code: APPR
Date received: 2022-09-30
Supplement type: Panel Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Eversense® E3 Continuous Glucose Monitoring System for modifying the device to reduce the frequency of calibration.