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| Device | Eversense Continuous Glucose Monitoring System |
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| Generic Name | Sensor, glucose, implanted, non-adjunctive use |
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| Applicant | Senseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876 |
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| PMA Number | P160048 |
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| Supplement Number | S006 |
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| Date Received | 11/26/2018 |
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| Decision Date | 06/06/2019 |
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| Product Code |
QHJ |
| Docket Number | 19M-2753 |
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| Notice Date | 06/06/2019 |
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| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT02154126
|
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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 | Yes |
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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 Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3) Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. The system is intended for single patient use. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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