PMA P120005S077

Device: G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S077
Product code: PQF
Decision date: 2018-10-11
Classification: Sensor, Glucose, Invasive, Non-adjunctive
Generic name: Sensor, glucose, invasive, non-adjunctive
Approval order statement: Approval for minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: G5 Mobile Continuous Glucose Monitoring System
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S077
Product code: PQF
Generic name: Sensor, glucose, invasive, non-adjunctive
Decision date: 2018-10-11
Decision code: APPR
Date received: 2018-08-08
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for minor design changes to the firmware installed on the transmitter component of the Dexcom G5 Continuous Glucose Monitoring System.