PMA P120005S088
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- Product code
- MDS
- Decision date
- 2022-01-20
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval of continuous pediatric enrollment for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Dexcom G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S088
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2022-01-20
- Decision code
- APPR
- Date received
- 2021-04-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of continuous pediatric enrollment for the post-approval study (PAS) protocol.