EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA premarket approval P160048 · decided 2018-06-21
Approval details
- PMA number
- P160048
- Trade name
- EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2016-10-26
- Decision date
- 2018-06-21
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- QCD
- 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 (18 years and older) with diabetes for up to 90 days.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
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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 |