PMA P150021S033

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S033
Product code: MDS
Decision date: 2018-09-19
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S033
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-09-19
Decision code: OK30
Date received: 2018-08-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.