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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
medtronic minimed 630g system with enlite

supplement #: S011
Medtronic Minimed Apr 20, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S012
Medtronic Minimed Apr 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S013
Medtronic Minimed Apr 14, 2017 change design/components/specifications/material  
minimed 630g insulin pump

supplement #: S014
Medtronic Minimed May 10, 2017 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 630g insulin pump

supplement #: S015
Medtronic Minimed Jun 06, 2017 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 630g system with enlite sensor

supplement #: S016
Medtronic Minimed Jun 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S017
Medtronic Minimed Jun 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard enlite sensor

supplement #: S019
Medtronic Minimed Aug 16, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard / guardian sensor (3)

supplement #: S020
Medtronic Minimed Oct 16, 2017 change design/components/specifications/material  
minimed 630g system

supplement #: S021
Medtronic Minimed Feb 13, 2018 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
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