PMA P160048S008
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S008
- Product code
- QCD
- Decision date
- 2019-01-28
- Classification
- Continuous Glucose Monitor, Implanted, Adjunctive Use
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Approval order statement
- Approval to label the Eversense Sensor as Magnetic Resonance (MR) Conditional.
Current openFDA PMA Record#
- Device
- Eversense Continuous Glucose Monitoring System
- Applicant
- Senseonics, Incorporated
- PMA number
- P160048
- Supplement
- S008
- Product code
- QCD
- Generic name
- Continuous glucose monitor, implanted, adjunctive use
- Decision date
- 2019-01-28
- Decision code
- APPR
- Date received
- 2018-12-11
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to label the Eversense Sensor as Magnetic Resonance (MR) Conditional.