| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | FreeStyle Libre 14 Day Flash Glucose Monitoring System |
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| Generic Name | Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated |
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| Applicant | Abbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda, CA 94502 |
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| PMA Number | P160030 |
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| Supplement Number | S017 |
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| Date Received | 04/10/2018 |
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| Decision Date | 07/23/2018 |
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| Product Code |
PZE |
| Docket Number | 18M-2886 |
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| Notice Date | 07/26/2018 |
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| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT03257501
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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