PMA P120005S052

Device: G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S052
Product code: MDS
Decision date: 2016-08-25
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: Addition of G4 PLATINUM Transmitter manufacturing space. The G4 PLATINUM Transmitter is a component of the G4 PLATINUM Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S052
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2016-08-25
Decision code: OK30
Date received: 2016-07-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of G4 PLATINUM Transmitter manufacturing space. The G4 PLATINUM Transmitter is a component of the G4 PLATINUM Continuous Glucose Monitoring System.