PMA P120005S073
- Device
- G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S073
- Product code
- PQF
- Decision date
- 2018-07-03
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- Approval for minor design changes to the Dexcom G5 transmitter hardware and firmware. The Dexcom G5 transmitter is part of the Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM).
Current openFDA PMA Record#
- Device
- G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S073
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2018-07-03
- Decision code
- APPR
- Date received
- 2018-04-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the Dexcom G5 transmitter hardware and firmware. The Dexcom G5 transmitter is part of the Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM).