PMA P120005S079

Device: Dexcom G5 Platinum Contiuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S079
Product code: MDS
Decision date: 2018-12-04
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Qualification of existing equipment for addition of sensor packaging and final release steps at the Dexcom Mesa, Arizona manufacturing site for the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) system.

Current openFDA PMA Record#

Device: Dexcom G5 Platinum Contiuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S079
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-12-04
Decision code: OK30
Date received: 2018-11-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of existing equipment for addition of sensor packaging and final release steps at the Dexcom Mesa, Arizona manufacturing site for the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) system.