PMA P050012S002

Device: DEXCOM STS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S002
Product code: MDS
Decision date: 2006-08-21
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR DESIGN REVISIONS TO THE ACCESSORY SOFTWARE PROGRAM TO ENABLE IT TO BE USED FOR CONSUMER USE. THE SOFTWARE PROGRAM, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DM-CONSUMER AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER.

Current openFDA PMA Record#

Device: DEXCOM STS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S002
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2006-08-21
Decision code: APPR
Date received: 2006-07-28
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 ENABLE IT TO BE USED FOR CONSUMER USE. THE SOFTWARE PROGRAM, AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME DEXCOM DM-CONSUMER AND IS INDICATED FOR USE BY CONSUMERS TO ALLOW FOR THE TRANSFER OF GLUCOSE DATA STORED BY THE DEXCOM STS SYSTEM INTO A PERSONAL COMPUTER.