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 G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | DEXCOM, INC. 6340 SEQUENCE DR SAN DIEGO, CA 92121 |
PMA Number | P120005 |
Supplement Number | S053 |
Date Received | 07/28/2016 |
Decision Date | 10/26/2016 |
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 modifications to the Dexcom G5 Mobile Transmitter firmware. The new transmitter firmware version comprises changes to the battery voltage limits, and correction of anomalies for a real time clock range error, firmware version display error, and an unrecoverable transmitter error at initialization. The Dexcom G5 Mobile Transmitter is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System. |
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