PMA P120005S053

Device: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S053
Product code: MDS
Decision date: 2016-10-26
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
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.

Current openFDA PMA Record#

Device: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S053
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-10-26
Decision code: APPR
Date received: 2016-07-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.