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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.
 
 
6 supplements returned for P180008

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
t:slim x2 insulin pump with basal-iq technology

Tandem Diabetes Care, Inc. Jun 21, 2018   Approval Order
Summary of Safety & Effectiveness
Labeling
t:slim x2 insulin pump with basal-iq technology

supplement #: S001
Tandem Diabetes Care, Inc. Nov 29, 2018 change design/components/specifications/material  
t:slim x2 insulin pump with basal-iq technology

supplement #: S002
Tandem Diabetes Care, Inc. Nov 29, 2018 change design/components/specifications/material  
t:slim x2 insulin pump with basal-iq technology

supplement #: S003
Tandem Diabetes Care, Inc. Nov 29, 2018 change design/components/specifications/material  
t:slim x2 insulin pump with basal-iq technology

supplement #: S005
Tandem Diabetes Care, Inc. Oct 11, 2018 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with basal-iq technology

supplement #: S006
Tandem Diabetes Care, Inc. Oct 26, 2018 process change - manufacturer/sterilizer/packager/supplier  
t:slim x2 insulin pump with basal-iq technology

supplement #: S007
Tandem Diabetes Care, Inc. Dec 19, 2019 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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