PMA P120005S014

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S014
Product code: MDS
Decision date: 2014-03-05
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S014
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-03-05
Decision code: APPR
Date received: 2013-12-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE.