PMA P120005S030

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S030
Product code: MDS
Decision date: 2014-12-12
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: MANUFACTURING CHANGE IN THE LAYER APPLICATION PROCESS FOR THE G4PLATINUM SENSOR, WHICH IS A COMPONENT OF THE DEXCOM G4¿ PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S030
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2014-12-12
Decision code: OK30
Date received: 2014-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING CHANGE IN THE LAYER APPLICATION PROCESS FOR THE G4PLATINUM SENSOR, WHICH IS A COMPONENT OF THE DEXCOM G4¿ PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.