PMA P120005S006
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S006
- Product code
- MDS
- Decision date
- 2013-06-28
- Classification
- Sensor, Glucose, Invasive
- Generic name
- Sensor, glucose, invasive
- Approval order statement
- CHANGE TO THE SEMI-AUTOMATED ASSEMBLY EQUIPMENT FOR THREE SUB-ASSEMBLIES (CANNULA, PUSHROD CARRIER, AND NEEDLE CARRIER).
Current openFDA PMA Record#
- Device
- DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
- Applicant
- Dexcom, Inc.
- PMA number
- P120005
- Supplement
- S006
- Product code
- MDS
- Generic name
- Sensor, glucose, invasive
- Decision date
- 2013-06-28
- Decision code
- OK30
- Date received
- 2013-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SEMI-AUTOMATED ASSEMBLY EQUIPMENT FOR THREE SUB-ASSEMBLIES (CANNULA, PUSHROD CARRIER, AND NEEDLE CARRIER).