PMA P120005S025

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S025
Product code: MDS
Decision date: 2014-07-24
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE TRANSMITTER PACKAGING TRAY TO INCREASE MOLD CAPACITY AT THEIR SUPPLIER. THE TRANSMITTER IS A COMPONENT OF THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S025
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-07-24
Decision code: OK30
Date received: 2014-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE TRANSMITTER PACKAGING TRAY TO INCREASE MOLD CAPACITY AT THEIR SUPPLIER. THE TRANSMITTER IS A COMPONENT OF THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.