PMA P160048S013
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S013
- Product code
- QHJ
- Decision date
- 2019-08-29
- Classification
- Continuous Glucose Monitor, Implanted, Adjunctive Use
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Approval order statement
- New manufacturing site for the electronics assembly and encasement process for 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
- S013
- Product code
- QHJ
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Decision date
- 2019-08-29
- Decision code
- OK30
- Date received
- 2019-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New manufacturing site for the electronics assembly and encasement process for the sensor component of the Eversense continuous glucose monitoring system.