PMA P120005S067

Device: Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S067
Product code: MDS
Decision date: 2018-05-07
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for the addition of a Manufacturing Site for components of the G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems at your facility located at 232 South Dobson Rd., Mesa, Arizona.

Current openFDA PMA Record#

Device: Dexcom G4 Platinum Continuous Glucose Monitoring System and Dexcom 5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S067
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2018-05-07
Decision code: APPR
Date received: 2017-10-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of a Manufacturing Site for components of the G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems at your facility located at 232 South Dobson Rd., Mesa, Arizona.