PMA P120005S061

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S061
Product code: MDS
Decision date: 2017-04-26
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Relocate storage and shipping activities for finished products for the Dexcom G4 Platinum Contiuous Glucose Monitoring Systemand the Dexcom G5 Mobile Continuous Glucose Monitoring System to a new warehouse facility.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S061
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2017-04-26
Decision code: OK30
Date received: 2017-04-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocate storage and shipping activities for finished products for the Dexcom G4 Platinum Contiuous Glucose Monitoring Systemand the Dexcom G5 Mobile Continuous Glucose Monitoring System to a new warehouse facility.