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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 INSULIN PUMP
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS054
Date Received12/30/2014
Decision Date01/22/2016
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, RESPECTIVELY.
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