PMA P120005S065
- Device
- Dexcon G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S065
- Product code
- PQF
- Decision date
- 2017-09-21
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- Approval for firmware modifications to the touchscreen receiver in the Dexcom G5 Mobile Glucose Monitoring System.
Current openFDA PMA Record#
- Device
- Dexcon G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S065
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2017-09-21
- Decision code
- APPR
- Date received
- 2017-07-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware modifications to the touchscreen receiver in the Dexcom G5 Mobile Glucose Monitoring System.