PMA P120005S038

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S038
Product code: MDS
Decision date: 2015-11-06
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING DESIGN FOR THE SENSOR/ APPLICATOR FOR THE G4 PLATINUM CGM SYSTEM AND THE MANUFACTURING LINE FOR THIS NEW PACKAGING.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S038
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2015-11-06
Decision code: APPR
Date received: 2015-08-10
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE PACKAGING DESIGN FOR THE SENSOR/ APPLICATOR FOR THE G4 PLATINUM CGM SYSTEM AND THE MANUFACTURING LINE FOR THIS NEW PACKAGING.