PMA P120005S037

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S037
Product code: MDS
Decision date: 2015-09-23
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S037
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-09-23
Decision code: APPR
Date received: 2015-07-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS.