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T:SLIM G4 Insulin Pump with Dexcom G4 Platinum CGM System

FDA PMA

Class III (US FDA PMA)

PMA P140015

by Tandem Diabetes Care, Inc.

Identity

Trade Name
T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM FDA PMA
Generic Name
Pump, infusion, insulin, to be used with invasive glucose sensor FDA PMA

Identifiers

PMA Number
P140015 FDA PMA
FDA Product Code
OYC FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Clinical Chemistry FDA PMA
FDA Decision
APPR Approved FDA PMA

The T:SLIM G4 Insulin Pump with Dexcom G4 Platinum CGM System is a combination device consisting of the T:SLIM G4 insulin pump paired with the Dexcom G4 Platinum sensor and transmitter. It is intended for the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, and for receiving and displaying continuous glucose measurements as part of the T:SLIM G4 system.

The system is indicated for use in individuals 12 years of age and greater, requires a prescription, and is intended for single patient use. It aids in detecting episodes of hyperglycemia and hypoglycemia to facilitate acute and long-term therapy adjustments. Interpretation of results should be based on trends and patterns seen with several sequential readings over time.

Frequently asked questions

What is the T:SLIM G4 Insulin Pump with Dexcom G4 Platinum CGM System intended for?

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. When used as part of the T:SLIM G4 system, it receives and displays continuous glucose measurements from the Dexcom G4 Platinum sensor and transmitter to aid in detecting trends and patterns in glucose levels.

Who is the T:SLIM G4 system indicated for use in?

The T:SLIM G4 system is indicated for use in individuals 12 years of age and greater, as stated in the device specifications. It requires a prescription and is intended for single patient use.

Does the T:SLIM G4 system replace standard home glucose monitoring devices?

No, the continuous glucose monitoring component of the T:SLIM G4 system is indicated as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. It is used to detect trends and track patterns in persons with diabetes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Tandem Diabetes Care, Inc.

Sources (1)

  • FDA PMA P140015 24 fields · synced Oct 6, 2026