PMA P160048S029
- Device
- EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S029
- Product code
- QHJ
- Decision date
- 2025-03-27
- Classification
- Clinical Chemistry
- 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 CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S029
- Product code
- QHJ
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Decision date
- 2025-03-27
- Decision code
- APPR
- Date received
- 2025-02-25
- 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.