PMA P120005S005

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S005
Product code: MDS
Decision date: 2013-08-14
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S005
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2013-08-14
Decision code: APPR
Date received: 2013-05-20
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED.