FDA.reportPublic FDA data

PMA P120005S068

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S068
Product code
MDS
Decision date
2017-11-14
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
New supplier of raw material for the manufacturing of blood glucose sensor probes. The probes are components in Dexom G4 Platinum Continous Glucose Monitoring System and the Dexcom G5 Mobile Continous Glucose Monitoring System.

Current openFDA PMA Record#

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S068
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2017-11-14
Decision code
OK30
Date received
2017-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
New supplier of raw material for the manufacturing of blood glucose sensor probes. The probes are components in Dexom G4 Platinum Continous Glucose Monitoring System and the Dexcom G5 Mobile Continous Glucose Monitoring System.