Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S037 |
Date Received | 07/16/2015 |
Decision Date | 09/23/2015 |
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 THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS. |
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