PMA P120005S007
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S007
- Product code
- MDS
- Decision date
- 2013-08-09
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- ADD AN ALTERNATE DEXCOM SUPPLIER OF A COMPONENT USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
Current openFDA PMA Record#
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S007
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2013-08-09
- Decision code
- OK30
- Date received
- 2013-07-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN ALTERNATE DEXCOM SUPPLIER OF A COMPONENT USED IN THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.