PMA P120005S064
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S064
- Product code
- MDS
- Decision date
- 2017-08-11
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for minor design changes to the firmware installed on the receiver component of the Dexcom G5 Continuous Glucose Monitoring System.
Current openFDA PMA Record#
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S064
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2017-08-11
- Decision code
- APPR
- Date received
- 2017-06-29
- 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 receiver component of the Dexcom G5 Continuous Glucose Monitoring System.