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LINOX(SMART) S & LINOX(SMART) T Steroid-Eluting Dual-Coil ICD Leads

FDA PMA

Class III (US FDA PMA)

PMA P980023

by Biotronik, Inc.

Identity

Trade Name
PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM FDA PMA
Generic Name
Implantable cardioverter defibrillator (non-CRT) FDA PMA

Identifiers

PMA Number
P980023 FDA PMA
FDA Product Code
LWS FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The LINOX(SMART) S & LINOX(SMART) T are steroid-eluting dual-coil implantable cardioverter defibrillator (ICD) leads manufactured by Biotronik. These leads are designed to deliver electrical therapy and sense cardiac activity in patients with ventricular arrhythmias.

They are supplied as part of the Phylax ICD system and are intended for implantation in patients who have survived cardiac arrest due to ventricular tachyarrhythmia or have recurrent poorly tolerated sustained ventricular tachycardia. The leads are implantable devices and are not MRI safe unless specifically labeled; sterility, single-use status, and storage conditions are not detailed in the provided data.

Frequently asked questions

What is the LINOX(SMART) S & LINOX(SMART) T device used for?

The LINOX(SMART) S & LINOX(SMART) T leads are used as part of an implantable cardioverter defibrillator (ICD) system to deliver electrical therapy and sense cardiac signals in patients at risk of sudden death due to ventricular arrhythmias, including those who have survived cardiac arrest or have recurrent poorly tolerated sustained ventricular tachycardia.

Who manufactures the LINOX(SMART) S & LINOX(SMART) T leads?

The LINOX(SMART) S & LINOX(SMART) T leads are manufactured by Biotronik, Inc., as stated in the manufacturer and applicant fields of the device data.

Are the LINOX(SMART) S & LINOX(SMART) T leads sterile and single-use?

The provided device data does not specify whether the LINOX(SMART) S & LINOX(SMART) T leads are sterile or single-use; therefore, no conclusion can be drawn about their sterility or reusability from the given information.

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
Biotronik, Inc.

Sources (1)

  • FDA PMA P980023 24 fields · synced Sep 18, 2026