PMA P120005S022

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S022
Product code: MDS
Decision date: 2014-07-10
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE TO THE CONDITIONING STEP OF MANUFACTURING THE SENSOR WIRE SUBCOMPONENT OF THE G4 SENSOR. THE G4 SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S022
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-07-10
Decision code: OK30
Date received: 2014-06-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE CONDITIONING STEP OF MANUFACTURING THE SENSOR WIRE SUBCOMPONENT OF THE G4 SENSOR. THE G4 SENSOR IS A COMPONENT OF THE G4 PLATINUM CONTINUOUSGLUCOSE MONITORING SYSTEM.