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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/05/2012
Decision Date09/26/2013
Product Code
OZO[ Registered Establishments with OZO ]
Docket Number 13M-1206
Notice Date 09/30/2013
Advisory Committee Clinical Chemistry
Clinical Trials NCT01112696
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the minimed 5300 system. This device is indicated for the following: minimed 530g system - the minimed 530g system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The minimed 530g system can be programmed to automatically suspend delivery of insulin when the sensor glucose value falls below a predefined threshold value. For additional information please refer to approval order.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S019 S020 S021 S022 
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S042 S043 S045 S047 S048 S049 S050 S051 S053 
S055 S056 S057 S058 S059 S060 S062 S063 S065 
S066 S067 S068 S069