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PMA P160048S002

Device
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S002
Product code
QCD
Decision date
2018-11-06
Classification
Continuous Glucose Monitor, Implanted, Adjunctive Use
Generic name
Continuous glucose monitor, implanted, adjunctive use
Approval order statement
Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.

Current openFDA PMA Record#

Device
Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S002
Product code
QCD
Generic name
Continuous glucose monitor, implanted, adjunctive use
Decision date
2018-11-06
Decision code
APPR
Date received
2018-08-07
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.