PMA P150021S042

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S042
Product code: MDS
Decision date: 2019-06-20
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Manufacturing change in the order of inspections of parts by a vision system during the sensor pack assembly for the Libre sensor. The Libre sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System and the Freestyle Libre 14 day Flash Glucose Monitoring System.

Current openFDA PMA Record#

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S042
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2019-06-20
Decision code: OK30
Date received: 2019-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing change in the order of inspections of parts by a vision system during the sensor pack assembly for the Libre sensor. The Libre sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System and the Freestyle Libre 14 day Flash Glucose Monitoring System.