PMA P050012S019

Device
DEXCOM SEVEN PLUS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S019
Product code
MDS
Decision date
2009-09-17
Generic name
Sensor, glucose, invasive
Approval order statement
ADDING AN ADDITIONAL SUPPLIER FOR THE DEXCOM APPLICATOR NEEDLES.

Current openFDA PMA Record#

Device
DEXCOM SEVEN PLUS SYSTEM
Applicant
Dexcom, Inc.
PMA number
P050012
Supplement
S019
Product code
MDS
Generic name
Sensor, glucose, invasive
Decision date
2009-09-17
Decision code
OK30
Date received
2009-08-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDING AN ADDITIONAL SUPPLIER FOR THE DEXCOM APPLICATOR NEEDLES.