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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.
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS065
Date Received03/18/2015
Decision Date04/16/2015
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of purchasing, receiving, and incoming inspection activities of certain external insulin pump components used in the manufacture of the paradigm real-time pump series and the minimed 530g series from the medtronic minimed northridge facility to the medtronic puerto rico operations company and fedex/3pl facilities in puerto rico. The paradigm real쳌]time family of insulin pumps and the minimed 530g insulin pump are components of the paradigm real-time/real-time revel systems and the minimed 530g system, respectively.