Eversense Continuous Glucose Monitoring System
FDA premarket approval P160048/S006 · decided 2019-06-06
Approval details
- PMA number
- P160048
- Supplement
- S006
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eversense Continuous Glucose Monitoring System
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2018-11-26
- Decision date
- 2019-06-06
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- QHJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Eversense 365 Continuous Glucose Monitoring (CGM) System (K241335) | Senseonics, Incorporated | 2024-09-16 |
| Eversense AP CGM System (DEN230052) | Senseonics, Incorporated | 2024-04-29 |