PMA P160048S011
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S011
- Product code
- QHJ
- Decision date
- 2019-08-29
- Classification
- Sensor, Glucose, Implanted, Non-adjunctive Use
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Approval order statement
- Approval for a design change to the sensor component of the Eversense Continuous Glucose Monitoring System.
Current openFDA PMA Record#
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S011
- Product code
- QHJ
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Decision date
- 2019-08-29
- Decision code
- APPR
- Date received
- 2019-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the sensor component of the Eversense Continuous Glucose Monitoring System.