PMA P050012S009

Device
DEXCOM STS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S009
Product code
MDS
Decision date
2007-04-10
Generic name
Sensor, glucose, invasive
Approval order statement
AUTOMATION FOR CONFORMAL COATING REMOVAL IN THE MANUFACTURE OF THE DEVICE.

Current openFDA PMA Record#

Device
DEXCOM STS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S009
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2007-04-10
Decision code
OK30
Date received
2007-03-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
AUTOMATION FOR CONFORMAL COATING REMOVAL IN THE MANUFACTURE OF THE DEVICE.