PMA P050012S038

Device
DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S038
Product code
MDS
Decision date
2011-08-12
Generic name
Sensor, glucose, invasive
Approval order statement
REMOVAL OF REDUNDANT DEBURRING STEPS FROM THE CLEANING PROCESSES OF THE NEEDLE AND CANNULA COMPONENTS OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.

Current openFDA PMA Record#

Device
DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S038
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2011-08-12
Decision code
OK30
Date received
2011-07-14
Supplement type
30-Day Notice
Approval order statement
REMOVAL OF REDUNDANT DEBURRING STEPS FROM THE CLEANING PROCESSES OF THE NEEDLE AND CANNULA COMPONENTS OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.