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 530G SYSTEM
• Generic Name: Automated insulin dosing , threshold suspend
• Applicant: Medtronic, Inc.; 18000 Devonshire St.; Northridge, CA 91325
• PMA Number: P120010
• Supplement Number: S101
• Date Received: 02/03/2017
• Decision Date: 10/11/2017
• Product Code: OZO
• Advisory Committee: Clinical Chemistry
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.