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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Devicet:slim X2 Insulin Pump with Basal-IQ Technology
Generic NameAutomated insulin dosing , threshold suspend
ApplicantTandem Diabetes Care, Inc.
11075 Roselle St.
San Diego, CA 92121
PMA NumberP180008
Supplement NumberS006
Date Received09/27/2018
Decision Date10/26/2018
Product Codes OZO PQF 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03195140
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change the procedure for wake button replacement during PCBA refurbishment by discontinuing replacement of the wake button if it meets specific criteria and by transferring various reprogramming steps in-house. The wake button switch assemblies are components of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and the t:slim Insulin Pump with Basal-IQ Technology.
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