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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 NumberS107
Date Received08/15/2023
Decision Date10/30/2023
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 battery cap assembly component of the 630G, 670G, 770G, and 780G pumps. The 630G, 670G, 770G, and 780G pumps are a part of the MiniMed 630G system, MiniMed 670G system, MiniMed 770G system and MiniMed 780G system, respectively.
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