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PMA P160048S027

Device
Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S027
Product code
QCD
Decision date
2024-02-22
Classification
Clinical Chemistry
Generic name
Continuous glucose monitor, implanted, adjunctive use
Approval order statement
to modify the Insertion Tools’s sterilization cycle parameters. The Insertion Tools are components of the Eversense E3 Continuous Glucose Monitoring System

Current openFDA PMA Record#

Device
Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S027
Product code
QCD
Generic name
Continuous glucose monitor, implanted, adjunctive use
Decision date
2024-02-22
Decision code
OK30
Date received
2024-01-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to modify the Insertion Tools’s sterilization cycle parameters. The Insertion Tools are components of the Eversense E3 Continuous Glucose Monitoring System