PMA P120005S048

Device: DEXCOM G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S048
Product code: MDS
Decision date: 2016-08-02
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for firmware changes to the Dexcom G5 Mobile Receiver to decrease occurrence of certain recoverable errors requiring a system reset. In addition, the firmware changes address customer complaints related to the recoverable errors. The Dexcom G5 Mobile Receiver is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: DEXCOM G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S048
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-08-02
Decision code: APPR
Date received: 2016-05-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for firmware changes to the Dexcom G5 Mobile Receiver to decrease occurrence of certain recoverable errors requiring a system reset. In addition, the firmware changes address customer complaints related to the recoverable errors. The Dexcom G5 Mobile Receiver is a component of the Dexcom G5® Mobile Continuous Glucose Monitoring System.