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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 PUMPS
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
ApplicantMEDTRONIC MINIMED
PMA NumberP120010
Supplement NumberS043
Date Received11/03/2014
Decision Date12/03/2014
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 
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the paradigm real-time system (mmt-522, mmt-722, mmt-522k, mmt-722k), the paradigm realtime revel system (mmt-523, mmt-723, mmt-523k, mmt-723k), and the minimed 530g system (mmt-551, mmt-751).
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