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PMA P150021S044

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S044
Product code
MDS
Decision date
2019-08-15
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Change to introduce an alternate supplier of a sensor component for the Libre sensor. The Libre sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System and the Freestyle Libre 14 day Flash Glucose Monitoring System.

Current openFDA PMA Record#

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S044
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-08-15
Decision code
OK30
Date received
2019-07-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to introduce an alternate supplier of a sensor component for the Libre sensor. The Libre sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System and the Freestyle Libre 14 day Flash Glucose Monitoring System.