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PMA P050012S014

Device
SEVEN SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S014
Product code
MDS
Decision date
2008-05-15
Generic name
Sensor, glucose, invasive
Approval order statement
APPROVAL FOR A DESIGN MODIFICATION TO ALLOW USERS OF THE DEXCOM SEVEN SYSTEM DM2 DATA MANAGER SOFTWARE TO OBTAIN RECEIVER FIRMWARE UPDATES ELECTRONICALLY AND REMOTELY USING THEIR PERSONAL COMPUTER.

Current openFDA PMA Record#

Device
SEVEN SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S014
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2008-05-15
Decision code
APPR
Date received
2008-04-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A DESIGN MODIFICATION TO ALLOW USERS OF THE DEXCOM SEVEN SYSTEM DM2 DATA MANAGER SOFTWARE TO OBTAIN RECEIVER FIRMWARE UPDATES ELECTRONICALLY AND REMOTELY USING THEIR PERSONAL COMPUTER.