Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Classification Name: sensor, glucose, invasive
• Generic Name: continuous glucose monitor
• Applicant: ABBOTT LABORATORIES
• PMA Number: P050020
• Supplement Number: S022
• Date Received: 02/04/2010
• Decision Date: 01/14/2011
• Product Code: MDS [ Registered Establishments with MDS ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: normal 180 day track
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for changes to the outgoing quality control (qc) solution testing.