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PMA P150021S048

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S048
Product code
MDS
Decision date
2020-04-13
Generic name
Sensor, glucose, invasive
Approval order statement
Update to the in-process optical setup and image processing for the vision systems that verify three Critical Quality Attributes of the glucose sensor puck. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.

Current openFDA PMA Record#

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S048
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2020-04-13
Decision code
OK30
Date received
2020-03-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the in-process optical setup and image processing for the vision systems that verify three Critical Quality Attributes of the glucose sensor puck. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.