PMA P120005S046

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S046
Product code: MDS
Decision date: 2016-04-21
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Qualification of additional manufacturing space for the manufacture of the G5 Mobile Transmitter. The G5 Mobile Transmitter is a component of the G5 Mobile Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S046
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-04-21
Decision code: OK30
Date received: 2016-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of additional manufacturing space for the manufacture of the G5 Mobile Transmitter. The G5 Mobile Transmitter is a component of the G5 Mobile Continuous Glucose Monitoring System.