PMA P120005S057
- Device
- DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S057
- Product code
- MDS
- Decision date
- 2017-06-06
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for the addition of the G5 Mobile Android App as an additional display device for use with a compatible smart device.
Current openFDA PMA Record#
- Device
- DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S057
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2017-06-06
- Decision code
- APPR
- Date received
- 2016-10-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the G5 Mobile Android App as an additional display device for use with a compatible smart device.