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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 NumberS001
Date Received08/31/2018
Decision Date11/29/2018
Product Codes OZO PQF 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03195140
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the occlusion detection software.
  We welcome your comments and feedback about Devices@FDA.
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