PMA P120005S081
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S081
- Product code
- MDS
- Decision date
- 2019-04-24
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Mobile Continuous Glucose Monitoring System.
Current openFDA PMA Record#
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S081
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2019-04-24
- Decision code
- APPR
- Date received
- 2019-03-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Mobile Continuous Glucose Monitoring System.