FDA.reportPublic FDA data

PMA P150021S041

Device
FreeStyle Libre Pro Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P150021
Supplement
S041
Product code
MDS
Decision date
2019-05-10
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Introduction of an additional circuit printing line used in the fabrication of the glucose sensor, which is a common component of the Freestyle Libre Flash Glucose Monitoring System, Freestyle Libre Pro Flash Glucose Monitoring System, and 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
S041
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2019-05-10
Decision code
OK30
Date received
2019-04-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of an additional circuit printing line used in the fabrication of the glucose sensor, which is a common component of the Freestyle Libre Flash Glucose Monitoring System, Freestyle Libre Pro Flash Glucose Monitoring System, and Freestyle Libre 14 day Flash Glucose Monitoring System.