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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, minimed 770g system

supplement #: S089
Medtronic Minimed, Inc. Apr 19, 2021 postapproval study protocol  
minimed 670g system and minimed 770g system

supplement #: S090
Medtronic Minimed, Inc. Feb 25, 2021 labeling change - indications/instructions/shelf life/tradename  
minimed 780g system

supplement #: S091
Medtronic Minimed, Inc. Apr 21, 2023 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 670g system, minimed 770g system

supplement #: S092
Medtronic Minimed, Inc. Jul 07, 2021 process change - manufacturer/sterilizer/packager/supplier  
minimed 770g system

supplement #: S093
Medtronic Minimed, Inc. Apr 27, 2023 change design/components/specifications/material  
minimed 670g system

supplement #: S094
Medtronic Minimed, Inc. Oct 05, 2021 process change - manufacturer/sterilizer/packager/supplier  
minimed™ 670g system

supplement #: S095
Medtronic Minimed, Inc. Dec 17, 2021 labeling change - indications/instructions/shelf life/tradename  
guardian sensor 3

supplement #: S096
Medtronic Minimed, Inc. Dec 16, 2022 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 670g insulin pump, medtronic minimed 770g insulin pump

supplement #: S098
Medtronic Minimed, Inc. Apr 28, 2022 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 670g system

supplement #: S099
Medtronic Minimed, Inc. Apr 28, 2022 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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