FDA.reportPublic FDA data

PMA P120005S044

Device
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S044
Product code
MDS
Decision date
2016-01-13
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
TO ADD AN ADDITIONAL CONTRACT LABORATORY FOR PERFORMING BIOBURDEN AND STERILITY TESTING, WHICH IS USED TO SUPPORT OF STERILIZATION VALIDATION OF THE G5 MOBILE/G4 PLATINUM SENSOR. THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMS.

Current openFDA PMA Record#

Device
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S044
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2016-01-13
Decision code
OK30
Date received
2015-12-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
TO ADD AN ADDITIONAL CONTRACT LABORATORY FOR PERFORMING BIOBURDEN AND STERILITY TESTING, WHICH IS USED TO SUPPORT OF STERILIZATION VALIDATION OF THE G5 MOBILE/G4 PLATINUM SENSOR. THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEMS.