PMA P160030S049

Device: Freestyle Libre 14-Day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S049
Product code: PZE
Decision date: 2022-03-02
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Addition of an alternate manufacturing site for the manufacture of a sensor membrane polymer component. 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 14-Day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S049
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2022-03-02
Decision code: OK30
Date received: 2022-02-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate manufacturing site for the manufacture of a sensor membrane polymer component. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System.