PMA P120005S059
- Device
- DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S059
- Product code
- PQF
- Decision date
- 2017-05-22
- Classification
- Sensor, Glucose, Invasive, Non-adjunctive
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S059
- Product code
- PQF
- Generic name
- Sensor, glucose, invasive, non-adjunctive
- Decision date
- 2017-05-22
- Decision code
- APPR
- Date received
- 2017-01-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.