PMA P160048S019
- Device
- Eversense E3 Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- Product code
- QHJ
- Decision date
- 2022-05-24
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record
- Device
- Eversense E3 Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S019
- Product code
- QHJ
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Decision date
- 2022-05-24
- Decision code
- APPR
- Date received
- 2022-04-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.