Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
FDA premarket approval P160048/S026 · decided 2023-12-05
Approval details
- PMA number
- P160048
- Supplement
- S026
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2023-08-11
- Decision date
- 2023-12-05
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- QCD
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- Approval for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM System.
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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 |