PMA P140015S026

Device

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Applicant

Tandem Diabetes Care, Inc.

PMA number

P140015

Supplement

S026

Product code

OYC

Decision date

2018-10-11

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

Removal of plasma treatment on the patient line, modification to the final packing verification process, and the addition of additional testing/acceptance criteria for the pumps. The Tandem cartridges and pumps are part of the Tandem t:slim X2 Insulin Pump system.

Summary

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