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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 Dexcom G5 Mobile CGM
Generic NamePump, infusion, insulin, to be used with invasive glucose sensor
ApplicantTandem Diabetes Care, Inc.
11045 Roselle Street
San Diego, CA 92121
PMA NumberP140015
Supplement NumberS020
Date Received03/01/2017
Decision Date08/25/2017
Product Codes OYC PQF 
Docket Number 17M-5262
Notice Date 09/05/2017
Advisory Committee Clinical Chemistry
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of the t:slim X2 Insulin Pump with the Dexcom G5 Mobile CGM and for modifying the indications for use to include pediatric patients ages 6-11 years and replace adjunctive with non-adjunctive CGM use (i.e., replace fingerstick blood glucose testing for diabetes treatment decisions). This device is indicated as follows:The t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (“t:slim X2 System”) consists of the t:slim X2 Insulin Pump paired with the Dexcom G5 Mobile Sensor and Transmitter. 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 System to receive and display continuous glucose measurements from the Dexcom G5 Mobile Sensor and Transmitter. The t:slim X2 System also includes continuous glucose monitoring (CGM) indicated for the management of diabetes. The Dexcom G5 Mobile CGM is designed to replace fingerstick blood glucose testing for diabetes treatment decisions. The t:slim X2 System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the t:slim X2 System results should be based on the trends and patterns seen with several sequential readings over time. The t:slim X2 System is indicated for use in individuals 6 years of age and greater. The t:slim X2 System is intended for single patient use and requires a prescription. The device is indicated for use with NovoLog or Humalog U-100 insulin.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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