PMA P120005S043

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S043
Product code: MDS
Decision date: 2016-01-14
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: ADDITION OF A CONTRACT STERILIZER FOR THE G5 MOBILE/G4 PLATINUM SENSOR. THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINIOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S043
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-01-14
Decision code: OK30
Date received: 2015-12-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A CONTRACT STERILIZER FOR THE G5 MOBILE/G4 PLATINUM SENSOR. THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM.