| 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 CONTIUOUS GLUCOSE MONITORING SYSTEM |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | DEXCOM, INC.
6340 SEQUENCE DR
SAN DIEGO, CA 92121 |
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| PMA Number | P120005 |
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| Supplement Number | S049 |
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| Date Received | 06/21/2016 |
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| Decision Date | 09/16/2016 |
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| Product Code |
MDS |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT01514292
|
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Approval for updates to the G5 Mobile iOS App Software and G5 Mobile Transmitter Firmware for Dexcom’s G5 Mobile Continuous Glucose Monitoring System. The App is being modified to: backfill data from the CGM if there are data gaps within the last 3 hours; include mute override settings, which allow users to hear alerts critical to safe and effective use of the device even when their smart device is muted or turned to a very low volume; and to correct software anomalies. The Transmitter Firmware is being modified to: transmit data for backfill in the App; improve efficiency of battery usage on the transmitter; expand transmitter database logging to include additional information; support internal engineering efforts; and to correct software anomalies. |
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