FDA.reportPublic FDA data

PMA P120005S074

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S074
Product code
MDS
Decision date
2018-06-13
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Addition of an alternate speaker supplier for the G5 Mobile Receiver. The G5 Mobile Receiver is part of the Dexcom G5 Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S074
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-06-13
Decision code
OK30
Date received
2018-05-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate speaker supplier for the G5 Mobile Receiver. The G5 Mobile Receiver is part of the Dexcom G5 Continuous Glucose Monitoring System.