FDA.reportPublic FDA data

PMA P120005S086

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S086
Product code
MDS
Decision date
2020-01-08
Generic name
Sensor, glucose, invasive
Approval order statement
Addition of a Clean Environment Room and associated support rooms to the existing manufacturing space for manufacturing sensors of the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) System.

Current openFDA PMA Record#

Device
Dexcom G5 Mobile Continuous Glucose Monitoring System
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S086
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2020-01-08
Decision code
OK30
Date received
2019-12-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a Clean Environment Room and associated support rooms to the existing manufacturing space for manufacturing sensors of the G4 PLATINUM/G5 Mobile Continuous Glucose Monitoring (CGM) System.