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PMA P150021S045

Device
FreeStyle Libre 14 day Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S045
Product code
MDS
Decision date
2019-09-12
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Update to the shipping pallet configuration, removal of the temperature controls from shipping, and extending in-process shelf life of foil-bagged glucose sensor reels. The glucose sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.

Current openFDA PMA Record#

Device
FreeStyle Libre 14 day Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S045
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-09-12
Decision code
OK30
Date received
2019-08-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the shipping pallet configuration, removal of the temperature controls from shipping, and extending in-process shelf life of foil-bagged glucose sensor reels. The glucose sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.