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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

Medtronic Minimed, Inc. Sep 28, 2016   Approval Order
Summary of Safety & Effectiveness
Labeling
minimed 670g system

supplement #: S001
Medtronic Minimed, Inc. Nov 15, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g insulin pump

supplement #: S002
Medtronic Minimed, Inc. Nov 10, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S003
Medtronic Minimed, Inc. Feb 02, 2017 change design/components/specifications/material  
minimed 670g system

supplement #: S004
Medtronic Minimed, Inc. Dec 22, 2016 postapproval study protocol  
minimed 670g system

supplement #: S005
Medtronic Minimed, Inc. Dec 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
minimed 670g system

supplement #: S006
Medtronic Minimed, Inc. Dec 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
guardian link transmitter

supplement #: S007
Medtronic Minimed, Inc. Dec 19, 2016 process change - manufacturer/sterilizer/packager/supplier  
guardian link (3) transmitter

supplement #: S008
Medtronic Minimed, Inc. Feb 10, 2017 change design/components/specifications/material  
medtronic minimed hybrid closed loop (hcl) 670g

supplement #: S010
Medtronic Minimed, Inc. Apr 20, 2017 process change - manufacturer/sterilizer/packager/supplier  
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