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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMiniMed 630G System
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150001
Supplement NumberS104
Date Received01/26/2023
Decision Date04/18/2023
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a minor design change to the Next Generation Pumps (NGP) to remove remote bolus functionality, remove remote settings modification, and disable over the air programming. The proposed changes address vulnerabilities in connection with Field Action (FA1272) and will be implemented in the MiniMed 670G and 630G Insulin Pumps.
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