PMA P120005S087
- Device
- G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S087
- Product code
- MDS
- Decision date
- 2020-09-03
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Approval of the interim analysis for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- G5 Mobile Continuous Glucose Monitoring System
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S087
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2020-09-03
- Decision code
- APPR
- Date received
- 2020-08-06
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the interim analysis for the post-approval study (PAS) protocol.