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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namepump, infusion, insulin, to be used with invasive glucose sensor
PMA NumberP140015
Date Received07/17/2014
Decision Date09/08/2015
Product Code
OYC[ Registered Establishments with OYC ]
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the t:slim g4 insulin pump with dexcom g4 platinum cgm (¿t:slim g4 system¿). This device consists of the t:slim g4 insulin pump paired with the dexcom g4 platinum sensor and transmitter. The t:slim g4 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 g4 insulin pump can be used solely for continuous insulin delivery and as part of the t:slim g4 system to receive and display continuous glucose measurements from the dexcom g4 platinum sensor and transmitter. The t:slim g4 system also includes continuous glucose monitoring (cgm) indicated for detecting trends and tracking patterns in persons with diabetes for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The t:slim g4 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 g4 system results should be based on the trends and patterns seen with several sequential readings over time. The t:slim g4 system is indicated for use in individuals 12 years of age and greater. The t:slim g4 system is intended for single patient use and requires a prescription.