PMA P050012S035

Device: DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S035
Product code: MDS
Decision date: 2011-09-02
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO REPLACE THE PASTE IN THE SURFACE MOUNT TECHNOLOGY (SMT) COMPONENT SOLDERING PROCESS FOR THE TRANSMITTER COMPONENT OF THE DEVICE.

Current openFDA PMA Record#

Device: DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S035
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2011-09-02
Decision code: APPR
Date received: 2010-12-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO REPLACE THE PASTE IN THE SURFACE MOUNT TECHNOLOGY (SMT) COMPONENT SOLDERING PROCESS FOR THE TRANSMITTER COMPONENT OF THE DEVICE.