PMA P050012S041
- Device
- DEXCOM SEVEN AND SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S041
- Product code
- MDS
- Decision date
- 2011-09-30
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR A MANUFACTURING CHANGE TO IMPLEMENT A NEW SPRAY FIXTURE IN DEXCOM¿S SENSOR MEMBRANE SPRAY SYSTEM.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN AND SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S041
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2011-09-30
- Decision code
- APPR
- Date received
- 2011-08-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING CHANGE TO IMPLEMENT A NEW SPRAY FIXTURE IN DEXCOM¿S SENSOR MEMBRANE SPRAY SYSTEM.