PMA P120005S055

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S055
Product code: MDS
Decision date: 2016-12-09
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for firmware modifications to the receiver component in the following Dexcom Continuous Glucose Monitoring Systems: G4 PLATINUM, G4 PLATINUM (Professional), G4 PLATINUM with Share, and G4 PLATINUM with Share for Pediatrics.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S055
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-12-09
Decision code: APPR
Date received: 2016-09-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for firmware modifications to the receiver component in the following Dexcom Continuous Glucose Monitoring Systems: G4 PLATINUM, G4 PLATINUM (Professional), G4 PLATINUM with Share, and G4 PLATINUM with Share for Pediatrics.