PMA P160030S051

Device: FreeStyle Libre 14 day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S051
Product code: PZE
Decision date: 2022-04-28
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of 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: S051
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2022-04-28
Decision code: OK30
Date received: 2022-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of the FreeStyle Libre 14-Day and FreeStyle Libre Pro Glucose Monitoring Systems.