PMA P120005S075

Device: Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S075
Product code: MDS
Decision date: 2018-06-15
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Addition of a new supplier of glucose oxidase for manufacture of glucose sensors for G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S075
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-06-15
Decision code: OK30
Date received: 2018-05-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new supplier of glucose oxidase for manufacture of glucose sensors for G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems.