Eversense® E3 Continuous Glucose Monitoring System
FDA premarket approval P160048/S016 · decided 2022-02-10
Approval details
- PMA number
- P160048
- Supplement
- S016
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eversense® E3 Continuous Glucose Monitoring System
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2020-09-30
- Decision date
- 2022-02-10
- Days to decision
- 498 days
- Decision code
- APPR
- Product code
- QHJ
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.
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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 |