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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 NumberS033
Date Received08/11/2014
Decision Date10/08/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to a supplier¿s production line for a motor part of the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin pumps (models mmt-523, mmt-523k, mmt-723 and mmt-723k) and the minimed 530g insulin pumps (models mmt-551 and mmt-751). The insulin pumps are components of the paradigm real-time continuous glucose monitoring system, paradigm real-time revel continuous glucose monitoring system, and the minimed 530g system respectively.