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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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29 supplements returned for P140015

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
t:slim x2 insulin pump with dexcom g5 mobile cgm

supplement #: S020
Tandem Diabetes Care, Inc. Aug 25, 2017 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
t:slim g4 insulin pump with dexcom g4 platinum cgm

supplement #: S021
Tandem Diabetes Care, Inc. Dec 21, 2017 location change - manufacturer/sterilizer/packager/supplier  
g4 insulin pump with dexcom g4 platinum cgm system

supplement #: S022
Tandem Diabetes Care, Inc. Jun 15, 2017 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with dexcom g5 mobile cgm

supplement #: S023
Tandem Diabetes Care, Inc. Feb 14, 2018 process change - manufacturer/sterilizer/packager/supplier  
t:slim g4 insulin pump with dexcom g4 platinum cgm (t:slim g4 system); t:slim x2 insulin pump with dexcom g5 mobile cgm

supplement #: S024
Tandem Diabetes Care, Inc. Apr 17, 2018 change design/components/specifications/material  
t:slim x2 insulin pump with dexcomg5 mobile cgm system

supplement #: S025
Tandem Diabetes Care, Inc. May 02, 2018 change design/components/specifications/material  
t:slim x2 insulin pump with dexcom g5 mobile cgm

supplement #: S026
Tandem Diabetes Care, Inc. Oct 11, 2018 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with dexcom g5 mobile cgm

supplement #: S027
Tandem Diabetes Care, Inc. Oct 26, 2018 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with dexcom g5 mobile cgm system

supplement #: S028
Tandem Diabetes Care, Inc. Mar 01, 2019 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with dexcom g5 mobile cgm system

supplement #: S029
Tandem Diabetes Care, Inc. Dec 19, 2019 process change - manufacturer/sterilizer/packager/supplier  
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