PMA P050012S031
- Device
- DEXCON SEVEN AND SEVEN PLUS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S031
- Product code
- MDS
- Decision date
- 2010-09-09
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL FOR A CHANGE FROM A SINGLE TO FOUR-CAVITY PRODUCTION MOLD AS WELL AS THE ADDITION OF AN ALTERNATIVE GATE LOCATION FOR THE SENSOR SAFETY LOCK.
Current openFDA PMA Record#
- Device
- DEXCON SEVEN AND SEVEN PLUS
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S031
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2010-09-09
- Decision code
- APPR
- Date received
- 2010-07-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE FROM A SINGLE TO FOUR-CAVITY PRODUCTION MOLD AS WELL AS THE ADDITION OF AN ALTERNATIVE GATE LOCATION FOR THE SENSOR SAFETY LOCK.