PMA P050012S025

Device: DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S025
Product code: MDS
Decision date: 2010-07-15
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO INCLUDE MORE EMPHASIS ON THE ALERT TO USERS ABOUT THE POTENTIAL FOR THE TIPS OF SENSORS BREAKING OFF AND TO PROVIDE RECOMMENDATIONS TO USERS REGARDING THEIR ACTIONS SHOULD THIS OCCUR.

Current openFDA PMA Record#

Device: DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S025
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2010-07-15
Decision code: APPR
Date received: 2010-06-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING TO INCLUDE MORE EMPHASIS ON THE ALERT TO USERS ABOUT THE POTENTIAL FOR THE TIPS OF SENSORS BREAKING OFF AND TO PROVIDE RECOMMENDATIONS TO USERS REGARDING THEIR ACTIONS SHOULD THIS OCCUR.