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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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99 supplements returned for P150001

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Device Name Company Date Approved Supplement Reason Other Information
medtronic minimed 630g system

supplement #: S043
Medtronic Minimed Apr 20, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian glucose sensor (3)

supplement #: S044
Medtronic Minimed Jun 07, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g insulin pump

supplement #: S045
Medtronic Minimed Jul 02, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S046
Medtronic Minimed Jun 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system

supplement #: S047
Medtronic Minimed Jul 16, 2018 process change - manufacturer/sterilizer/packager/supplier  
medtronic minimed 630g system with guardian sensor (3)/ guardian sensor (3)

supplement #: S048
Medtronic Minimed Aug 03, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S049
Medtronic Minimed Aug 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g insulin pump, guardian link (3) transmitter

supplement #: S050
Medtronic Minimed Nov 20, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S051
Medtronic Minimed Aug 14, 2018 process change - manufacturer/sterilizer/packager/supplier  
minimed 630g system with smartguard

supplement #: S052
Medtronic Minimed Nov 29, 2018 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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