PMA P050012S018

Device: DEXCOM SEVEN SYSTEMS
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S018
Product code: MDS
Decision date: 2009-05-05
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM. THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC). THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIFIED IN THE SUBMISSION.

Current openFDA PMA Record#

Device: DEXCOM SEVEN SYSTEMS
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S018
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2009-05-05
Decision code: APPR
Date received: 2009-03-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO PROVIDE ADDITIONAL SUPPLEMENTARY INFORMATION TO USERS ON GLUCOSE TRENDS AND PATTERNS DOWNLOADED TO THE PROGRAM. THE SOFTWARE PROGRAM, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DATA MANAGER 3 (DM3) AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS OR SEVEN SYSTEMS INTO A PERSONAL COMPUTER (PC). THE SOFTWARE MODIFICATIONS INCLUDED SEVERAL NEW FEATURES AS IDENTIFIED IN THE SUBMISSION.