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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMINIMED 530G SYSTEM
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
ApplicantMEDTRONIC MINIMED
PMA NumberP120010
Supplement NumberS056
Date Received01/06/2015
Decision Date03/20/2015
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional manufacturing testing to be performed on a different version of a component used in the manufacture of the minimed 530g insulin pump mmt-551, mmt-751 that is part of the minimed 530g system.
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