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: Enlite Sensor
• Generic Name: Automated insulin dosing , threshold suspend
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P150001
• Supplement Number: S002
• Date Received: 10/14/2016
• Decision Date: 11/08/2016
• Product Code: OZO
• 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  
Additional plasma equipment used during manufacture of the Enlite sensor at the Medtronic’s sensor substrate supplier.