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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
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS016
Date Received03/06/2014
Decision Date06/03/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE SOFTWARE TO THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751). THESE CHANGES INCLUDE CORRECTIONS FOR TWO MOTOR ERROR ANOMALIES AND THREE THRESHOLD SUSPEND ANOMALIES, AND ENHANCEMENTS FOR THE THRESHOLD SUSPEND FEATURE, INSULIN VALUE SETTING, AND MERGED COMMON CODE BASE.
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