PMA P120005S020
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S020
- Product code
- MDS
- Decision date
- 2014-06-18
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO INCREASE THE MANUFACTURING SPACE TO SUPPORT NEW CLEANENVIRONMENT AND MATERIAL TRANSFER ROOMS FOR G4 PLATINUM SENSOR/APPLICATORS.
Current openFDA PMA Record#
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S020
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2014-06-18
- Decision code
- OK30
- Date received
- 2014-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO INCREASE THE MANUFACTURING SPACE TO SUPPORT NEW CLEANENVIRONMENT AND MATERIAL TRANSFER ROOMS FOR G4 PLATINUM SENSOR/APPLICATORS.