PMA P160048S017
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S017
- Product code
- QHJ
- Decision date
- 2020-12-11
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Approval order statement
- approval for adding a new component manufacturing line at a previously approved supplier
Current openFDA PMA Record#
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S017
- Product code
- QHJ
- Generic name
- Sensor, glucose, implanted, non-adjunctive use
- Decision date
- 2020-12-11
- Decision code
- OK30
- Date received
- 2020-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for adding a new component manufacturing line at a previously approved supplier