PMA P120005S051

Device: G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM/DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S051
Product code: MDS
Decision date: 2016-08-12
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Extending the temperature excursion period for the Dexcom G5 Mobile/G4 PLATINUM Sensor. The proposed change seeks to extend the allowable temperature excursion period for the sensor component in its primary packaging. The Dexcom G5 Mobile/G4 PLATINUM Sensor is a component of the Dexcom G5 Mobile and the Dexcom G4 Platinum Continuous Glucose Monitoring System, respectively.

Current openFDA PMA Record#

Device: G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM/DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S051
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-08-12
Decision code: OK30
Date received: 2016-07-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extending the temperature excursion period for the Dexcom G5 Mobile/G4 PLATINUM Sensor. The proposed change seeks to extend the allowable temperature excursion period for the sensor component in its primary packaging. The Dexcom G5 Mobile/G4 PLATINUM Sensor is a component of the Dexcom G5 Mobile and the Dexcom G4 Platinum Continuous Glucose Monitoring System, respectively.