PMA P150021S061

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S061
Product code: MDS
Decision date: 2026-09-01
Classification: Clinical Chemistry
Generic name: Sensor, glucose, invasive
Approval order statement: addition of a secondary supplier and manufacturer for subcomponents and subassemblies for sensor kits. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems

Current openFDA PMA Record#

Device: Freestyle Libre Pro Flash Glucose Monitoring System
Applicant: Abbott Diabetes Care, Inc.
PMA number: P150021
Supplement: S061
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2026-09-01
Decision code: OK30
Date received: 2026-08-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a secondary supplier and manufacturer for subcomponents and subassemblies for sensor kits. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems