- Device
- Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S028
- Product code
- QCD
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Decision date
- 2024-10-23
- Decision code
- OK30
- Date received
- 2024-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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