PMA P160030S039

Device: Freestyle Libre 14 day Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
Product code: PZE
Decision date: 2020-05-12
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Approval order statement: Approval for 1) introducing an alternate adhesive used in the assembly of the sensor puck; 2) introducing an additional sensor puck assembly manufacturing line at an existing manufacturing site; and 3) introducing a new ISO 8 cleanroom in which the additional assembly line will be located. The sensor puck is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash 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: S039
Product code: PZE
Generic name: Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Decision date: 2020-05-12
Decision code: APPR
Date received: 2019-10-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) introducing an alternate adhesive used in the assembly of the sensor puck; 2) introducing an additional sensor puck assembly manufacturing line at an existing manufacturing site; and 3) introducing a new ISO 8 cleanroom in which the additional assembly line will be located. The sensor puck is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems.