PMA P050012S049
- Device
- DEXCOM SEVEN CONTINUOUS GLUCOSE SYSTEM, DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S049
- Product code
- MDS
- Decision date
- 2012-10-23
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO A TORQUE DRIVER USED IN THE RECEIVER COMPONENT ASSEMBLY PROCESS OF THE DEVICE.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN CONTINUOUS GLUCOSE SYSTEM, DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S049
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2012-10-23
- Decision code
- OK30
- Date received
- 2012-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A TORQUE DRIVER USED IN THE RECEIVER COMPONENT ASSEMBLY PROCESS OF THE DEVICE.