PMA P140015S020

Device

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Applicant

Tandem Diabetes Care, Inc.

PMA number

P140015

Supplement

S020

Product code

OYC

Decision date

2017-08-25

Classification

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Generic name

Pump, infusion, insulin, to be used with invasive glucose sensor

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.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140015S020B.pdf" target="_new">Summary of Safety and Effectiveness</a>