Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
• Generic Name: Sensor, glucose, invasive
• Applicant: Abbott Laboratories; 1360 S. Loop Rd.; Alameda, CA 94502
• PMA Number: P050020
• Supplement Number: S019
• Date Received: 08/27/2009
• Decision Date: 09/21/2009
• Withdrawal Date: 03/18/2013
• Product Code: MDS
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
ADDING AN ALTERNATE MANUFACTURER FOR THE INSERTER ASSEMBLY PROCESS.