PMA P120005S080
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S080
- Product code
- MDS
- Decision date
- 2019-03-15
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval for changes to the interim analysis.
Current openFDA PMA Record#
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S080
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2019-03-15
- Decision code
- APPR
- Date received
- 2019-01-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for changes to the interim analysis.