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: MINIMED 630G SYSTEM WITH SMARTGUARD
• Generic Name: Automated insulin dosing , threshold suspend
• Applicant: Medtronic Minimed; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P150001
• Supplement Number: S009
• Date Received: 12/23/2016
• Decision Date: 03/27/2017
• Product Code: OZO
• Advisory Committee: Clinical Chemistry
• Supplement Type: Real-Time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for revisions to patient labeling to include instructions for how users should apply a second Enlite Overtape over the Enlite Sensor.