PMA P150021S035

Device: Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S035
Product code: MDS
Decision date: 2018-12-21
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for modification of the membrane layer formulation of the FreeStyle Libre and FreeStyle Libre Pro sensor components and an addition of a shipping method for shipment of sensor components.

Current openFDA PMA Record#

Device: Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S035
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-12-21
Decision code: APPR
Date received: 2018-09-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modification of the membrane layer formulation of the FreeStyle Libre and FreeStyle Libre Pro sensor components and an addition of a shipping method for shipment of sensor components.