PMA P120005S089
- Device
- G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S089
- Product code
- MDS
- Decision date
- 2021-12-21
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for the modification of the G5 Mobile Android Continuous Glucose Monitoring (CGM) Application software used with the G5 Mobile CGM System.
Current openFDA PMA Record#
- Device
- G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S089
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2021-12-21
- Decision code
- APPR
- Date received
- 2021-09-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the modification of the G5 Mobile Android Continuous Glucose Monitoring (CGM) Application software used with the G5 Mobile CGM System.