|
Device | DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S025 |
Date Received | 06/26/2014 |
Decision Date | 07/24/2014 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE MANUFACTURING PROCESS OF THE TRANSMITTER PACKAGING TRAY TO INCREASE MOLD CAPACITY AT THEIR SUPPLIER. THE TRANSMITTER IS A COMPONENT OF THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM. |