PMA P120005S049

Device: DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S049
Product code: MDS
Decision date: 2016-09-16
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
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.

Current openFDA PMA Record#

Device: DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S049
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-09-16
Decision code: APPR
Date received: 2016-06-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.