PMA P050012S048
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S048
- Product code
- MDS
- Decision date
- 2012-08-03
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- ADDITION OF AN ALTERNATIVE COMPONENT SUPPLIER. ACTIMED, FOR THE PUSHROD AND CANNULA COMPONENTS OF THE SENSOR APPLICATOR OF THE DEVICE.
Current openFDA PMA Record#
- Device
- DEXCOM SEVEN PLUS SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P050012
- Supplement
- S048
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2012-08-03
- Decision code
- OK30
- Date received
- 2012-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATIVE COMPONENT SUPPLIER. ACTIMED, FOR THE PUSHROD AND CANNULA COMPONENTS OF THE SENSOR APPLICATOR OF THE DEVICE.