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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.
 
DeviceMINIMED 530G SYSTEM
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
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
NCT01148862
NCT01161043
NCT01464346
Expedited Review Granted? Yes
Combination Product No
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 themanagement 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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
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