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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
guardian sensor 3, guardian 4 sensor

supplement #: S114
Medtronic Minimed, Inc. Jan 03, 2024 process change - manufacturer/sterilizer/packager/supplier  
guardian™ sensor 3, guardian™ 4 sensor

supplement #: S115
Medtronic Minimed, Inc. Jan 05, 2024 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 780g insulin pump (mmt-1884), medtronic minimed 780g insulin pump kit (mmt-1894)

supplement #: S116
Medtronic Minimed, Inc. Apr 19, 2024 change design/components/specifications/material  
minimed 670g pump, minimed 770g pump, guardian link (3) transmitter, guardian sensor (3), contour next link 2.4 meter, r

supplement #: S117
Medtronic Minimed, Inc. Mar 21, 2024 postapproval study protocol  
minimed 780g system

supplement #: S118
Medtronic Minimed, Inc. Apr 18, 2025 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
guardian 4 sensor

supplement #: S119
Medtronic Minimed, Inc. Jul 17, 2024 process change - manufacturer/sterilizer/packager/supplier  
minimed 780g system

supplement #: S120
Medtronic Minimed, Inc. Oct 07, 2024 labeling change - indications/instructions/shelf life/tradename  
minimed 780g system

supplement #: S121
Medtronic Minimed, Inc. Oct 10, 2024 postapproval study protocol  
minimed 770g system

supplement #: S122
Medtronic Minimed, Inc. Aug 20, 2025 labeling change - pas  
minimed 770g insulin pump; minimed 780g insulin pump

supplement #: S123
Medtronic Minimed, Inc. May 09, 2025 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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