|
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 | S019 |
Date Received | 04/16/2014 |
Decision Date | 07/11/2014 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE TRANSMITTER THAT COMBINES THE COMPONENTS FROM TWO PRINTED CIRCUIT BOARD ASSEMBLIES (PCBAS) INTO A SINGLE BOARD TRANSMITTER (SBT) WITH ONE PRINTED CIRCUIT BOARD (PCB). |