Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans
FDA premarket approval P160048/S028 · decided 2024-10-23
Approval details
- PMA number
- P160048
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Applicant
- Senseonics, Incorporated
- Date received
- 2024-09-27
- Decision date
- 2024-10-23
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- QCD
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Germantown, MD
- Statement
- to move finished Eversense Insertion Tool device manufacturing activities from one building to the neighboring building within the same establishment that has the same FEI. The Eversense Insertion Tool is a component of the Eversense E3 Continuous Glucose Monitoring 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 |