FreeStyle Libre Pro Flash Glucose Monitoring System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM FDA PMA
- Generic Name
- Sensor, glucose, invasive FDA PMA
Identifiers
- PMA Number
- P150021 FDA PMA
- FDA Product Code
- MDS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Clinical Chemistry FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device classified as a Sensor, Glucose, Invasive. It is designed to detect glucose trends and track patterns in individuals aged 18 and older with diabetes, providing healthcare professionals with real-time data for clinical assessment. The system does not require user calibration with blood glucose values and is intended for use by trained professionals under prescription.
The system is supplied as a Class III medical device with a Premarket Approval (PMA) from the FDA (P150021). It is intended for professional use only, with sensor readings accessible to patients through consultation with healthcare providers. The device operates as a single-use, non-sterile disposable sensor system, and its use is governed by regulatory approvals specific to its invasive glucose monitoring function. No MRI safety information or reusable components are indicated in the specifications.
Frequently asked questions
What is the FreeStyle Libre Pro intended for in clinical practice and who can use it?
The FreeStyle Libre Pro is a professional continuous glucose monitoring (CGM) system designed for healthcare professionals to detect glucose trends and track patterns in adults aged 18 and older with diabetes. It is intended for clinical assessment only and requires a prescription. Patients access sensor readings only through consultation with trained healthcare providers, as the system is not meant for self-monitoring without professional guidance.
Is the FreeStyle Libre Pro sensor reusable or single-use, and what does that mean for clinical workflows?
The FreeStyle Libre Pro sensor is a single-use, non-sterile disposable system. This means each sensor is intended for one-time use by a single patient, reducing the risk of cross-contamination and ensuring accurate glucose monitoring. Clinicians will need to replace the sensor as needed, following the manufacturer’s guidelines for proper disposal and handling.
What regulatory pathway does the FreeStyle Libre Pro follow, and how does that affect its use?
The FreeStyle Libre Pro is classified as a Class III medical device and holds a **Premarket Approval (PMA)** from the FDA (P150021). This approval confirms its compliance with rigorous safety and effectiveness standards for invasive glucose monitoring. Its professional-use designation means it is restricted to trained healthcare providers under prescription, ensuring proper clinical oversight and adherence to regulatory requirements.
Are there multiple sensor sizes or models available for the FreeStyle Libre Pro, and how does that impact patient selection?
The FreeStyle Libre Pro system includes multiple sensor models, as indicated by the listed FEI numbers (e.g., 3004139819, 3010893867). These variations may correspond to different patient needs, such as sensor length or application sites, though exact specifications (e.g., size ranges) are not detailed in the data. Clinicians should verify compatibility with their patient population and consult manufacturer documentation to select the appropriate model.
How should the FreeStyle Libre Pro sensors be stored, and what considerations should clinicians keep in mind?
The FreeStyle Libre Pro sensors are non-sterile and single-use, so storage should follow standard medical device protocols to maintain integrity until use. Since they are disposable, clinicians should store them in a clean, dry environment away from direct sunlight or extreme temperatures. Proper labeling and expiration tracking are also recommended to ensure timely use and avoid waste.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P150021 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Diabetes Care Inc
- FDA Applicant
- Abbott Diabetes Care, Inc.
Sources (1)
- FDA PMA P150021 24 fields · synced Sep 18, 2026