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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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134 supplements returned for P120010

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Device Name Company Date Approved Supplement Reason Other Information
enlite sensor

supplement #: S022
Medtronic, Inc. May 14, 2014 process change - manufacturer/sterilizer/packager/supplier  
minilink real-time transmitter

supplement #: S023
Medtronic, Inc. Oct 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite glucose sensor

supplement #: S024
Medtronic, Inc. Feb 19, 2015 change design/components/specifications/material  
enlite glucose sensor

supplement #: S025
Medtronic, Inc. Jul 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
minilink transmitter, watertight tester, minilink kit with enlite serter and minilink replacement kit

supplement #: S026
Medtronic, Inc. Feb 04, 2015 labeling change - indications/instructions/shelf life/tradename  
enlite glucose sensor

supplement #: S027
Medtronic, Inc. Jul 24, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S028
Medtronic, Inc. Jul 22, 2014 process change - manufacturer/sterilizer/packager/supplier  
enlite sensor

supplement #: S029
Medtronic, Inc. Nov 12, 2015 change design/components/specifications/material  
enlite sensor

supplement #: S030
Medtronic, Inc. Feb 04, 2015 change design/components/specifications/material  
enlite glucose sensor

supplement #: S031
Medtronic, Inc. Aug 28, 2014 process change - manufacturer/sterilizer/packager/supplier  
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