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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 INSULIN PUMP
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificail pancreas device system, threshold suspend
Applicant MEDTRONIC INC.
PMA NumberP120010
Supplement NumberS005
Date Received11/08/2013
Decision Date08/21/2014
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 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.
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