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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 530G System
Generic Nameautomated insulin dosing , threshold suspend
ApplicantMEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS139
Date Received01/27/2021
Decision Date02/25/2021
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an update to product labeling to warn against a new interference by Hydroxyurea to the continuous glucose monitoring (CGM) component of the system.
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