PMA P160030S050

Device: Freestyle Libre 14-Day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S050
Product code: PZE
Decision date: 2022-03-16
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Addition of a manufacturing site for the manufacture of a sensor electrode material. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre 14-Day Flash Glucose Monitoring System.

Current openFDA PMA Record#

Device: Freestyle Libre 14-Day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S050
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2022-03-16
Decision code: OK30
Date received: 2022-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a manufacturing site for the manufacture of a sensor electrode material. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre 14-Day Flash Glucose Monitoring System.