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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 INC.
PMA NumberP120010
Supplement NumberS032
Date Received08/01/2014
Decision Date09/29/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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