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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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99 supplements returned for P150001

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Device Name Company Date Approved Supplement Reason Other Information
minimed 630g system with smartguard(tm)

Medtronic Minimed Aug 10, 2016   Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 630g pump

supplement #: S001
Medtronic Minimed Sep 30, 2016 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S002
Medtronic Minimed Nov 08, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g pump

supplement #: S003
Medtronic Minimed Jan 06, 2017 change design/components/specifications/material  
minimed 630g system with smartguard

supplement #: S004
Medtronic Minimed Dec 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
guradian link transmitter

supplement #: S005
Medtronic Minimed Dec 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S006
Medtronic Minimed Dec 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S007
Medtronic Minimed Jan 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S008
Medtronic Minimed Jun 02, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S009
Medtronic Minimed Mar 27, 2017 labeling change - indications/instructions/shelf life/tradename  
  We welcome your comments and feedback about Devices@FDA.
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