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: S019
• Date Received: 08/27/2009
• Decision Date: 09/21/2009
• Product Code: MDS [ Registered Establishments with MDS ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Adding an alternate manufacturer for the inserter assembly process.