PMA P050012S016
- Device
- DEXCOM SEVEN SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S016
- Product code
- MDS
- Decision date
- 2009-02-13
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE RECEIVER USER INTERFACE AND ALGORITHM, AND MODIFICATIONS TO THE TRANSMITTER TO MAKE IT COMPATIBLE TO THE MODIFIED RECEIVER ALGORITHM.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S016
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2009-02-13
- Decision code
- APPR
- Date received
- 2008-08-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE RECEIVER USER INTERFACE AND ALGORITHM, AND MODIFICATIONS TO THE TRANSMITTER TO MAKE IT COMPATIBLE TO THE MODIFIED RECEIVER ALGORITHM.