PMA P120005S078

Device: G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S078
Product code: MDS
Decision date: 2018-10-04
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Extending the relative humidity excursion period for the Dexcom G4 PLATINUM/G5 Mobile Sensor. The proposed change seeks to extend the allowable relative humidity excursion period for the sensor component in its primary packaging. The Dexcom G4 PLATINUM/G5 Mobile Sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring System, respectively.

Current openFDA PMA Record#

Device: G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S078
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-10-04
Decision code: OK30
Date received: 2018-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Extending the relative humidity excursion period for the Dexcom G4 PLATINUM/G5 Mobile Sensor. The proposed change seeks to extend the allowable relative humidity excursion period for the sensor component in its primary packaging. The Dexcom G4 PLATINUM/G5 Mobile Sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring System, respectively.