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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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54 supplements returned for P160007

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
guardian connect system

Medtronic Minimed Mar 08, 2018   Approval Order
Summary of Safety & Effectiveness
Labeling
guardian connect system

supplement #: S001
Medtronic Minimed May 23, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S002
Medtronic Minimed Apr 20, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian glucose sensor (3)

supplement #: S003
Medtronic Minimed Jun 07, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian sensor (3)

supplement #: S004
Medtronic Minimed Aug 16, 2018 change design/components/specifications/material  
guardian sensor (3) system

supplement #: S005
Medtronic Minimed Jun 26, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S006
Medtronic Minimed Jun 28, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S007
Medtronic Minimed Jul 16, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system / guardian sensor (3)

supplement #: S008
Medtronic Minimed Aug 03, 2018 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S009
Medtronic Minimed Aug 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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