PMA P120005S076
- Device
- G5 Mobile Continuous Glucose Monitoring Systems
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S076
- Product code
- MDS
- Decision date
- 2018-06-22
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- Add an additional contract manufacturer for touchscreen components used in the manufacturing of the G5 Mobile Continuous Glucose Monitoring (CGM) System.
Current openFDA PMA Record#
- Device
- G5 Mobile Continuous Glucose Monitoring Systems
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S076
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2018-06-22
- Decision code
- OK30
- Date received
- 2018-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional contract manufacturer for touchscreen components used in the manufacturing of the G5 Mobile Continuous Glucose Monitoring (CGM) System.