FDA.reportPublic FDA data

PMA P160048S026

Device
Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S026
Product code
QCD
Decision date
2023-12-05
Classification
Clinical Chemistry
Generic name
Continuous glucose monitor, implanted, adjunctive use
Approval order statement
Approval for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM 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
S026
Product code
QCD
Generic name
Continuous glucose monitor, implanted, adjunctive use
Decision date
2023-12-05
Decision code
APPR
Date received
2023-08-11
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM System.