PMA P120005S069

Device: Dexcon G4 PLATINUM and G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S069
Product code: MDS
Decision date: 2018-01-10
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Additional manufacturing line for the transmitter component of the Dexcom G4 PLATINUM and G5 Mobile continuous glucose monitoring systems.

Current openFDA PMA Record#

Device: Dexcon G4 PLATINUM and G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S069
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-01-10
Decision code: OK30
Date received: 2017-12-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Additional manufacturing line for the transmitter component of the Dexcom G4 PLATINUM and G5 Mobile continuous glucose monitoring systems.