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PMA P160030S053

Device
FreeStyle Libre 14 day Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P160030
Supplement
S053
Product code
PZE
Decision date
2023-06-30
Classification
Clinical Chemistry
Generic name
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement
Introduction of a secondary supplier for components of the Sensor Applicator and the Sensor Pack for the Freestyle Libre 14 Day and Freestyle Libre Pro glucose monitoring systems.

Current openFDA PMA Record#

Device
FreeStyle Libre 14 day Flash Glucose Monitoring System
Applicant
Abbott Diabetes Care, Inc.
PMA number
P160030
Supplement
S053
Product code
PZE
Generic name
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date
2023-06-30
Decision code
OK30
Date received
2023-05-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a secondary supplier for components of the Sensor Applicator and the Sensor Pack for the Freestyle Libre 14 Day and Freestyle Libre Pro glucose monitoring systems.