PMA P120005S083
- Device
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S083
- Product code
- PQF
- Decision date
- 2019-11-01
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- Approval for updates to the protocol (PTL901895, V004), including addition of the Dexcom G6 CGM.
Current openFDA PMA Record#
- Device
- DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S083
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2019-11-01
- Decision code
- APPR
- Date received
- 2019-06-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for updates to the protocol (PTL901895, V004), including addition of the Dexcom G6 CGM.