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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 780g system

supplement #: S124
Medtronic Minimed, Inc. Aug 29, 2025 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness &  Labeling 2
minimed 780g system

supplement #: S125
Medtronic Minimed, Inc. Dec 11, 2025 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness &  Labeling 2
minimed 670g system

supplement #: S126
Medtronic Minimed, Inc. Aug 25, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed 780g system

supplement #: S127
Medtronic Minimed, Inc. Oct 09, 2025 location change - manufacturer/sterilizer/packager/supplier  
minimed 780g system

supplement #: S128
Medtronic Minimed, Inc. Sep 12, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S129
Medtronic Minimed, Inc. Oct 02, 2025 labeling change - indications/instructions/shelf life/tradename  
minimed 670g system; minimed 770g system; minimed 780g system

supplement #: S130
Medtronic Minimed, Inc. Oct 16, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system minimed 770g system minimed 780g system

supplement #: S131
Medtronic Minimed, Inc. Dec 10, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed 780g system

supplement #: S132
Medtronic Minimed, Inc. Dec 05, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S133
Medtronic Minimed, Inc. Dec 18, 2025 postapproval study protocol  
  We welcome your comments and feedback about Devices@FDA.
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