PMA P120005S062

Device: Dexom G4 PLATINUM Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S062
Product code: MDS
Decision date: 2017-05-04
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Add a transmitter printed circuit board assembly (PCBA) reset station during manufacturing of the G5 Mobile Transmitters which is a component of Dexcom G5 Mobile Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: Dexom G4 PLATINUM Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S062
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2017-05-04
Decision code: OK30
Date received: 2017-04-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a transmitter printed circuit board assembly (PCBA) reset station during manufacturing of the G5 Mobile Transmitters which is a component of Dexcom G5 Mobile Continuous Glucose Monitoring System.