PMA P050012S011
- Device
- SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S011
- Product code
- MDS
- Decision date
- 2007-11-13
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR CALIBRATION OF THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM USING ANY FDA CLEARED BLOOD GLUCOSE METER.
Current openFDA PMA Record#
- Device
- SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S011
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2007-11-13
- Decision code
- APPR
- Date received
- 2007-06-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CALIBRATION OF THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM USING ANY FDA CLEARED BLOOD GLUCOSE METER.