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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 with Smart Guard
Generic Nameautomated insulin dosing , threshold suspend
18000 devonshire st
northridge, CA 91325
PMA NumberP150001
Supplement NumberS084
Date Received05/18/2020
Decision Date01/14/2021
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for manufacturing changes related to sterilization process for Guardian Sensor (3). The Guardian Sensor (3) is component of the MiniMed 670G System, the Guardian Connect System, and the MiniMed 630G System with SmartGuard.