PMA P050012S037
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S037
- Product code
- MDS
- Decision date
- 2011-06-03
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR REPLACEMENT OF AN OBSOLETE LCD IN THE RECEIVER ASSEMBLY WITH A SIMILAR COMPONENT AND MINOR MODIFICATIONS TO THE RECEIVER FIRMWARE TO ACCOMMODATE THE NEW HARDWARE.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S037
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2011-06-03
- Decision code
- APPR
- Date received
- 2011-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACEMENT OF AN OBSOLETE LCD IN THE RECEIVER ASSEMBLY WITH A SIMILAR COMPONENT AND MINOR MODIFICATIONS TO THE RECEIVER FIRMWARE TO ACCOMMODATE THE NEW HARDWARE.