FDA.reportPublic FDA data

PMA P120005S071

Device
Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S071
Product code
MDS
Decision date
2018-03-27
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
Removal of redundant inspection of the skived wire component, which will be processed further to manufacture the finished sensor probes. The sensors are components of the Dexcom G4 PLATINUM and Dexcom G5 Mobile Continuous Monitoring Systems.

Current openFDA PMA Record#

Device
Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S071
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2018-03-27
Decision code
OK30
Date received
2018-02-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Removal of redundant inspection of the skived wire component, which will be processed further to manufacture the finished sensor probes. The sensors are components of the Dexcom G4 PLATINUM and Dexcom G5 Mobile Continuous Monitoring Systems.