PMA P120005S024

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S024
Product code: MDS
Decision date: 2014-07-16
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE SENSOR LAYER DEPOSITION PROCESS FOR THE G4 PLATINUM SENSOR. THE G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4¿PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S024
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-07-16
Decision code: OK30
Date received: 2014-06-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE SENSOR LAYER DEPOSITION PROCESS FOR THE G4 PLATINUM SENSOR. THE G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4¿PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.