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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 Nameartificail pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS005
Date Received11/08/2013
Decision Date08/21/2014
Product Code
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 the implementation of a pneumatic press tool in place of a manual press tool in the manufacturing process of the paradigm real-time insulin pump (models:mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin-pump (models: mmt-523, mmt-523k, mmt-723, mmt-723k), guardian realtime monitor (models: css7100 and css17100k) and the minimed 530g insulin pump (models: mmt-551 and mmt-751). These parts are components of the paradigm real-time system, paradigm real-time revel system, guardian real-time continuous glucose monitoring systems and the minimed 530g system respectively.