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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 Street
San Diego, CA 92121
PMA NumberP180008
Supplement NumberS007
Date Received11/20/2019
Decision Date12/19/2019
Product Codes OZO PQF 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.
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