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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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123 supplements returned for P160017

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Device Name Company Date Approved Supplement Reason Other Information
minimed 670g system

supplement #: S023
Medtronic Minimed, Inc. Oct 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system with smartguard

supplement #: S024
Medtronic Minimed, Inc. Nov 07, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S026
Medtronic Minimed, Inc. Dec 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S027
Medtronic Minimed, Inc. Jan 03, 2018 postapproval study protocol  
minimed 670g system

supplement #: S028
Medtronic Minimed, Inc. Feb 14, 2018 change design/components/specifications/material  
medtronic minimed 670g system

supplement #: S029
Medtronic Minimed, Inc. Jan 19, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g pump

supplement #: S030
Medtronic Minimed, Inc. Feb 22, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S031
Medtronic Minimed, Inc. Jun 21, 2018 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 670g system

supplement #: S032
Medtronic Minimed, Inc. Feb 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S033
Medtronic Minimed, Inc. Feb 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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