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PMA P150021S043

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S043
Product code
MDS
Decision date
2019-08-13
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Addition of manufacturing space at Abbott Diabetes Care for the sensor component manufacturing process. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre 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
S043
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-08-13
Decision code
OK30
Date received
2019-07-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of manufacturing space at Abbott Diabetes Care for the sensor component manufacturing process. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System.