PMA P050012S003

Device
DEXCOM SHORT TERM GLUCOSE SENSOR (STS)
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S003
Product code
MDS
Decision date
2006-09-01
Generic name
Sensor, glucose, invasive
Approval order statement
RELEASE CRITERIA MODIFICATION TO THE METHOD USED FOR FINAL RELEASE CRITERIA OF THE DEXCOM STS SENSOR.

Current openFDA PMA Record#

Device
DEXCOM SHORT TERM GLUCOSE SENSOR (STS)
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S003
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2006-09-01
Decision code
OK30
Date received
2006-08-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
RELEASE CRITERIA MODIFICATION TO THE METHOD USED FOR FINAL RELEASE CRITERIA OF THE DEXCOM STS SENSOR.