PMA P050012S044
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S044
- Product code
- MDS
- Decision date
- 2012-03-08
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR A FIRMWARE MODIFICATION TO THE RECEIVED COMPONENT OF THE DEVICE IN ORDER TO INCREASE THE TONE AND DURATION OF USER ALERTS AND ALARMS.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN & SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S044
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2012-03-08
- Decision code
- APPR
- Date received
- 2012-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A FIRMWARE MODIFICATION TO THE RECEIVED COMPONENT OF THE DEVICE IN ORDER TO INCREASE THE TONE AND DURATION OF USER ALERTS AND ALARMS.