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Navistar, Navistar RMT, EZ Steer Nav Catheters

FDA PMA

Class III (US FDA PMA)

PMA P990025

by Biosense Webster Inc

Identity

Trade Name
NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER FDA PMA
Generic Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING FDA PMA

Identifiers

PMA Number
P990025 FDA PMA
FDA Product Code
DRF FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 870.1220 FDA PMA
Regulation Number
870.1220 FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Navistar, Navistar RMT, and EZ Steer Nav Catheters are electrode recording catheters designed for catheter-based cardiac mapping and ablation procedures. These devices feature a deflectable tip to facilitate precise navigation within the heart’s chambers, enabling detailed electroanatomical mapping and targeted radiofrequency ablation for arrhythmias such as accessory pathway–associated tachycardias and junctional reentrant tachycardia.

Intended for use in adults and children aged four and older, these catheters are supplied sterile and are classified as Class II medical devices under FDA regulations. They are reusable and must be compatible with a compatible radiofrequency generator for ablation applications. The devices are regulated under PMA number P990025 and fall under product code DRF, adhering to FDA approval standards for cardiovascular electrophysiology procedures.

Frequently asked questions

What are the Navistar catheters used for?

The Navistar catheters are designed for catheter-based cardiac mapping and ablation procedures, specifically for detailed electroanatomical mapping and targeted radiofrequency ablation of arrhythmias such as accessory pathway-associated tachycardias and junctional reentrant tachycardia.

Are these catheters reusable or single-use?

The Navistar catheters are reusable devices, meaning they can be used multiple times after proper cleaning and sterilization according to the manufacturer's instructions.

What age groups are these catheters intended for?

These catheters are intended for use in both adults and children aged four years and older for cardiac mapping and ablation procedures.

How are the Navistar catheters supplied?

The Navistar catheters are supplied sterile to ensure they are ready for immediate use in clinical procedures without requiring additional sterilization steps before first use.

What special equipment is needed to use these catheters?

These catheters must be used with a compatible radiofrequency generator for ablation applications, as they are designed to work with this specific equipment to perform the intended procedures.

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
Biosense Webster Inc
FDA Applicant
Biosense Webster, Inc.

Sources (1)

  • FDA PMA P990025 24 fields · synced Sep 18, 2026