PMA P160048S031
- Device
- Eversense® Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S031
- Product code
- QCD
- Decision date
- 2026-03-19
- Classification
- Clinical Chemistry
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Eversense® Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S031
- Product code
- QCD
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Decision date
- 2026-03-19
- Decision code
- APPR
- Date received
- 2026-02-23
- 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.