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Freestyle Libre Flash Glucose Monitoring System

FDA PMA

Class III (US FDA PMA)

PMA P160030

by Abbott Diabetes Care Inc

Identity

Trade Name
Freestyle Libre Flash Glucose Monitoring System FDA PMA
Generic Name
Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated FDA PMA

Identifiers

PMA Number
P160030 FDA PMA
FDA Product Code
PZE FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Clinical Chemistry FDA PMA
FDA Decision
APPR Approved FDA PMA

The Freestyle Libre Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions by detecting glucose trends and tracking patterns to aid in detecting episodes of hyperglycemia and hypoglycemia.

The system is intended for single patient use and requires a prescription. It is a factory-calibrated, user-initiated, invasive glucose sensor with authorization under FDA PMA (P160030). The device is supplied as a system for personal use in managing diabetes through trend-based therapy adjustments.

Frequently asked questions

What is the Freestyle Libre Flash Glucose Monitoring System intended to replace?

The system is designed to replace blood glucose testing for diabetes treatment decisions, as stated in the approval documentation, by providing continuous glucose monitoring through trend and pattern detection rather than relying on intermittent fingerstick measurements.

Who is the Freestyle Libre Flash Glucose Monitoring System intended for?

The system is indicated for the management of diabetes in persons age 18 and older, as explicitly specified in the approval statement and intended use description provided in the device data.

Is the Freestyle Libre Flash Glucose Monitoring System intended for single or multiple patient use?

The system is intended for single patient use, as clearly stated in the approval documentation: 'The System is intended for single patient use and requires a prescription.'

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FreeStyle Libre | Zuckerwerte ohne routinehaftes Fingerstechen, FreeStyle Libre 3 Sensor, Mein Bereich - FreeStyle Libre, FreeStyle Libre | FreeStyle Abbott, FreeStyle Libre Testprogramm – Kontinuierliche Glukosemessung …

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Diabetes Care Inc
FDA Applicant
Abbott Diabetes Care, Inc.

Sources (1)

  • FDA PMA P160030 24 fields · synced Sep 18, 2026