PMA P120005S063

Device: Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S063
Product code: MDS
Decision date: 2017-05-10
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Add a manufacturing site for the sensor wire subassembly which is a component of the Dexcom G5 Mobile/G4 PLATINUM Continuous Glucose Monitoring Systems.

Current openFDA PMA Record#

Device: Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S063
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2017-05-10
Decision code: OK30
Date received: 2017-04-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a manufacturing site for the sensor wire subassembly which is a component of the Dexcom G5 Mobile/G4 PLATINUM Continuous Glucose Monitoring Systems.