PMA P160048S016

Device: Eversense® E3 Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
Product code: QHJ
Decision date: 2022-02-10
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.

Current openFDA PMA Record#

Device: Eversense® E3 Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S016
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2022-02-10
Decision code: APPR
Date received: 2020-09-30
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.