PMA P050012S013

Device
DEXCOM SEVEN SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S013
Product code
MDS
Decision date
2008-01-11
Generic name
Sensor, glucose, invasive
Approval order statement
ADDITION OF A SUPPLIER FOR THE DEXCOM SENSOR SUB-ASSEMBLIES.

Current openFDA PMA Record#

Device
DEXCOM SEVEN SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S013
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2008-01-11
Decision code
OK30
Date received
2007-12-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A SUPPLIER FOR THE DEXCOM SENSOR SUB-ASSEMBLIES.