PMA P120005S060

Device: Dexcom G4 PLATINUM Continuous Glucose Monitoring System; Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S060
Product code: MDS
Decision date: 2017-11-03
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Approval for extending the environmental temperature upper limit for sensors and applicators while being stored at their sterilization site prior to undergoing sterilization, as well as for establishing a limit on the amount of time sensors and applicators may be stored at their sterilization site prior to undergoing sterilization.

Current openFDA PMA Record#

Device: Dexcom G4 PLATINUM Continuous Glucose Monitoring System; Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S060
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2017-11-03
Decision code: APPR
Date received: 2017-03-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for extending the environmental temperature upper limit for sensors and applicators while being stored at their sterilization site prior to undergoing sterilization, as well as for establishing a limit on the amount of time sensors and applicators may be stored at their sterilization site prior to undergoing sterilization.