PMA P160048S006

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
Product code: QHJ
Decision date: 2019-06-06
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval for the Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3) Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. The system is intended for single patient use.

Current openFDA PMA Record#

Device: Eversense Continuous Glucose Monitoring System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S006
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2019-06-06
Decision code: APPR
Date received: 2018-11-26
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3) Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. The system is intended for single patient use.