PMA P050012S047

Device: DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S047
Product code: MDS
Decision date: 2012-06-29
Generic name: Sensor, glucose, invasive
Approval order statement: MANUFACTURING CHANGE TO SEMI-AUTOMATE THE ASSEMBLY AND ULTRAVIOLET BONDING PROCESS FOR THE CANNULA CARRIER (MT9754-01), PUSHROD CARRIER (MT9755-01) AND NEEDLE CARRIER(MT9576-02) ASSEMBLIES USED IN THE SENSOR APPLICATOR COMPONENT OF THE DEVICE.

Current openFDA PMA Record#

Device: DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S047
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2012-06-29
Decision code: OK30
Date received: 2012-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING CHANGE TO SEMI-AUTOMATE THE ASSEMBLY AND ULTRAVIOLET BONDING PROCESS FOR THE CANNULA CARRIER (MT9754-01), PUSHROD CARRIER (MT9755-01) AND NEEDLE CARRIER(MT9576-02) ASSEMBLIES USED IN THE SENSOR APPLICATOR COMPONENT OF THE DEVICE.