PMA P120005S008

Device
DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S008
Product code
MDS
Decision date
2013-08-21
Classification
Sensor, Glucose, Invasive
Generic name
Sensor, glucose, invasive
Approval order statement
ADDITION OF NEW GOWNING ROOMS.

Current openFDA PMA Record#

Device
DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM
Applicant
Dexcom, Inc.
PMA number
P120005
Supplement
S008
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2013-08-21
Decision code
OK30
Date received
2013-07-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF NEW GOWNING ROOMS.