Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
Basic Information
- Device Name
- Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
- Trade Name
- FreeStyle Libre 14 Day Flash Glucose Monitoring System
- PMA Number
- P160030
- Supplement Number
- S017
- Device Class
- FDA Class 3
- Product Code
- PZE
- Generic Name
- Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 23, 2018
- Date Received
- April 10, 2018
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 18M-2886
Advisory Committee Statement
Approval for the FreeStyle Libre 14 Day Flash Glucose Monitoring System. The FreeStyle Libre 14 Day 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. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZE | Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated | FDA class 3 | Unknown |