PMA P050012S027
- Device
- DEXCON SEVEN AND SEVEN PLUS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S027
- Product code
- MDS
- Decision date
- 2010-11-16
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR A REDUCTION IN STANDOFF AS WELL AS ADDITION OF SHOCK MOUNTING ON THE RECEIVER UNIT OF THE DEVICE.
Current openFDA PMA Record#
- Device
- DEXCON SEVEN AND SEVEN PLUS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S027
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-11-16
- Decision code
- APPR
- Date received
- 2010-07-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A REDUCTION IN STANDOFF AS WELL AS ADDITION OF SHOCK MOUNTING ON THE RECEIVER UNIT OF THE DEVICE.