PMA P120005S082

Device: Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S082
Product code: MDS
Decision date: 2019-08-20
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for changes to improve drop impact resistance to the receiver component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System and Dexcom G5 Mobile Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S082
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2019-08-20
Decision code: APPR
Date received: 2019-06-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to improve drop impact resistance to the receiver component of the Dexcom G4 PLATINUM Continuous Glucose Monitoring System and Dexcom G5 Mobile Continuous Glucose Monitoring System.