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U.S. Department of Health and Human Services

Devices@FDA

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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
 
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134 supplements returned for P120010

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
minimed 530g system

Medtronic, Inc. Sep 26, 2013   Approval Order
Summary of Safety & Effectiveness
Labeling
enlite sensor

supplement #: S001
Medtronic, Inc. Oct 02, 2015 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S002
Medtronic, Inc. Dec 06, 2013 change design/components/specifications/material  
minilink real-time transmitter

supplement #: S003
Medtronic, Inc. Sep 25, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S004
Medtronic, Inc. Nov 23, 2015 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S005
Medtronic, Inc. Aug 21, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S006
Medtronic, Inc. Dec 05, 2013 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pump

supplement #: S008
Medtronic, Inc. Mar 13, 2014 change design/components/specifications/material  
minimed 530g insulin pump

supplement #: S009
Medtronic, Inc. Feb 27, 2014 process change - manufacturer/sterilizer/packager/supplier  
minimed 530g insulin pumps; enlite sensor

supplement #: S010
Medtronic, Inc. Mar 06, 2014 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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