PMA P120005S050
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S050
- Product code
- PQF
- Decision date
- 2017-03-08
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- Approval for a new touchscreen receiver component for the G5 Mobile Continuous Glucose Monitoring (CGM) System
Current openFDA PMA Record#
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S050
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2017-03-08
- Decision code
- APPR
- Date received
- 2016-06-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new touchscreen receiver component for the G5 Mobile Continuous Glucose Monitoring (CGM) System