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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

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
guardian sensor (3) (mmt-7020)

supplement #: S100
Medtronic Minimed, Inc. Apr 29, 2022 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 670g system, medtronic minimed 770g system

supplement #: S102
Medtronic Minimed, Inc. Oct 17, 2022 labeling change - indications/instructions/shelf life/tradename  
minimed 770g insulin pump

supplement #: S103
Medtronic Minimed, Inc. Oct 27, 2022 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 670g system, gs3 transfer to mproc, medtronic minimed 770g system, medtronic minimed 780g system

supplement #: S105
Medtronic Minimed, Inc. Dec 08, 2022 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system, minimedtm 770g system

supplement #: S106
Medtronic Minimed, Inc. Dec 16, 2022 labeling change - indications/instructions/shelf life/tradename  
minimed 670g system

supplement #: S108
Medtronic Minimed, Inc. Apr 18, 2023 change design/components/specifications/material  
medtronic minimed 670g system (mm670g), medtronic minimed 770g system (mm770g)

supplement #: S109
Medtronic Minimed, Inc. Mar 13, 2023 process change - manufacturer/sterilizer/packager/supplier  
minimed 780g system

supplement #: S110
Medtronic Minimed, Inc. Jun 15, 2023 postapproval study protocol  
guardian 4 sensor

supplement #: S111
Medtronic Minimed, Inc. Jul 06, 2023 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system, minimed 770g system and minimed 780g system

supplement #: S113
Medtronic Minimed, Inc. Oct 30, 2023 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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