- Device
- G5 Mobile Continuous Glucose Monitoring System, G6 Continuous Glucose Monitoring System, G7 Continuous Glucose Monitorin
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S091
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2024-01-09
- Decision code
- APPR
- Date received
- 2023-11-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for updates to the protocol (PTL901895, V006), including addition of the Dexcom G7 CGM.