FDA.reportPublic FDA data

PMA P160048S025

Device
Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant
Senseonics, Incorporated
PMA number
P160048
Supplement
S025
Product code
QHJ
Decision date
2023-06-09
Classification
Clinical Chemistry
Generic name
Sensor, glucose, implanted, non-adjunctive use
Approval order statement
Scale-up of a Sensor subassembly manufacturing process and the addition of a new supplier for a critical component 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
S025
Product code
QHJ
Generic name
Sensor, glucose, implanted, non-adjunctive use
Decision date
2023-06-09
Decision code
OK30
Date received
2023-05-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Scale-up of a Sensor subassembly manufacturing process and the addition of a new supplier for a critical component of the Eversense E3 Continuous Glucose Monitoring System.