PMA P160030S031

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
Product code: PZE
Decision date: 2019-05-06
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Approval for adding the FreeStyle LibreLink App for Android as a compatible reading device and alternative primary display for the FreeStyle Libre System and FreeStyle Libre 14 Day System.

Current openFDA PMA Record#

Device: Freestyle Libre Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P160030
Supplement: S031
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2019-05-06
Decision code: APPR
Date received: 2019-01-28
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for adding the FreeStyle LibreLink App for Android as a compatible reading device and alternative primary display for the FreeStyle Libre System and FreeStyle Libre 14 Day System.