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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 SmartGuard Technology
Generic Nameautomated insulin dosing , threshold suspend
ApplicantMEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP150001
Supplement NumberS092
Date Received09/20/2021
Decision Date10/05/2021
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of equivalent e-beam sterilization equipment at an approved site of a current contract sterilizer.
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