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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 #: S011
Medtronic Minimed, Inc. Apr 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g pump

supplement #: S012
Medtronic Minimed, Inc. May 10, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g insulin pump

supplement #: S013
Medtronic Minimed, Inc. Jun 06, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S014
Medtronic Minimed, Inc. Jun 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system/ guardian sensor (3)

supplement #: S016
Medtronic Minimed, Inc. Oct 16, 2017 change design/components/specifications/material  
minimed 670g system

supplement #: S017
Medtronic Minimed, Inc. Feb 13, 2018 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 670g system

supplement #: S018
Medtronic Minimed, Inc. Oct 31, 2017 change design/components/specifications/material  
medtronic minimed 67g insulin pump

supplement #: S019
Medtronic Minimed, Inc. Oct 11, 2017 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S020
Medtronic Minimed, Inc. Dec 08, 2017 change design/components/specifications/material  
guardian sensor (3)

supplement #: S021
Medtronic Minimed, Inc. Oct 23, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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