PMA P050012S046
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S046
- Product code
- MDS
- Decision date
- 2012-12-14
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- APPROVAL TO ADD AN ADDITIONAL SEALER IN THE POUCH SEALING PROCESS USED TO SEAL THE DEXCOM SEVEN SENSORS INTO TYVEK POROUS POUCHES.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S046
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2012-12-14
- Decision code
- APPR
- Date received
- 2012-03-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD AN ADDITIONAL SEALER IN THE POUCH SEALING PROCESS USED TO SEAL THE DEXCOM SEVEN SENSORS INTO TYVEK POROUS POUCHES.