PMA P160030S030

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
Product code: PZE
Decision date: 2019-10-07
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Approval for an alternate supplier for the PCB of the reader component of the FreeStyle Libre, FreeStyle Libre 14-day, and FreeStyle Libre Pro Flash Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S030
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2019-10-07
Decision code: APPR
Date received: 2019-01-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate supplier for the PCB of the reader component of the FreeStyle Libre, FreeStyle Libre 14-day, and FreeStyle Libre Pro Flash Continuous Glucose Monitoring Systems.