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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 g4 insulin pump with dexcom g4 platinum cgm

Tandem Diabetes Care, Inc. Sep 08, 2015   Approval Order
Summary of Safety & Effectiveness
Labeling
t:slim g4 insulin pump with dexcom g4 platinum cgm

supplement #: S001
Tandem Diabetes Care, Inc. Oct 08, 2015 process change - manufacturer/sterilizer/packager/supplier  
t slim g4 insulin pump with dexcom g4 platinum cgm system

supplement #: S002
Tandem Diabetes Care, Inc. Oct 08, 2015 process change - manufacturer/sterilizer/packager/supplier  
tslim g4 insulin pump with dexcom g4 platinum cgm system.

supplement #: S003
Tandem Diabetes Care, Inc. Oct 08, 2015 process change - manufacturer/sterilizer/packager/supplier  
t:slim g4 insulin pump with dexcom g4 platinum cgm system

supplement #: S004
Tandem Diabetes Care, Inc. Oct 08, 2015 process change - manufacturer/sterilizer/packager/supplier  
tslim g4 insulin pump with dexcom g4 platinum cgm system

supplement #: S005
Tandem Diabetes Care, Inc. Oct 15, 2015 process change - manufacturer/sterilizer/packager/supplier  
t:slim g4 insulin pump with dexcom g4 platinum cgm

supplement #: S006
Tandem Diabetes Care, Inc. Mar 24, 2016 change design/components/specifications/material  
t:slim g4 insulin pump with dexcom g4 platinum cgm

supplement #: S007
Tandem Diabetes Care, Inc. Jan 28, 2016 process change - manufacturer/sterilizer/packager/supplier  
t:slim g4 insulin pump with dexcon g4 platinum cgm

supplement #: S008
Tandem Diabetes Care, Inc. Jan 22, 2016 process change - manufacturer/sterilizer/packager/supplier  
t:slim g4 insulin pump with dexcom g4 platinum cgm

supplement #: S009
Tandem Diabetes Care, Inc. Jul 08, 2016 process change - manufacturer/sterilizer/packager/supplier  
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