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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
Date Received02/26/2018
Decision Date06/21/2018
Product Codes OZO PQF 
Docket Number 18M-2462
Notice Date 07/25/2018
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03195140
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of the t:slim X2 Insulin Pump with Basal-IQ Technology. This device is indicated as follows:The t:slim X2 Insulin Pump with Basal-IQ Technology (the System) consists of the t:slim X2 Insulin Pump which contains the Basal-IQ technology, and a continuous glucose monitor (CGM). Compatible CGMs include the Dexcom G5 Mobile CGM and integrated continuous glucose monitors (iCGMs) that are listed in the labeling for this device.The t:slim X2 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim X2 Insulin Pump with Basal-IQ Technology System.When the System is used with the Dexcom G5 Mobile CGM or a compatible iCGM, the Basal-IQ Technology can be used to suspend insulin delivery based on CGM sensor readings. The Dexcom G5 Mobile CGM Continuous Glucose Monitoring System (Dexcom G5) is indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the System results should be based on the trends and patterns seen with several sequential readings over time. The Dexcom G5 also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G5 is intended for single patient use and requires a prescription.The System is indicated for use in individuals 6 years of age and greater.The System is intended for single patient use and requires a prescription.The System is indicated for use with NovoLog or Humalog U-100 insulin.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S006 S007 
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