Identity
- Trade Name
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR FDA PMA
- Generic Name
- Cardiac ablation percutaneous catheter FDA PMA
Identifiers
- PMA Number
- P990071 FDA PMA
- FDA Product Code
- LPB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The EZ STEER THERMOCOOL CATHETERS are deflectable-tip, percutaneous cardiac ablation catheters designed to deliver radiofrequency (RF) energy during cardiac ablation procedures. These devices fall under the classification of cardiac ablation percutaneous catheters and are intended for use with the Stockert 70 RF Generator System to treat arrhythmias by creating controlled tissue lesions in the heart.
These catheters are supplied sterile for single-use and are regulated under an FDA Premarket Approval (PMA). They are intended for use in electrophysiology laboratories by trained healthcare professionals. The devices are compatible with the Stockert 70 RF Generator and feature a deflectable tip for precise navigation within the cardiac chambers. Storage and handling instructions are detailed in the accompanying instructions for use.
Frequently asked questions
Are the EZ STEER THERMOCOOL CATHETERS designed for reuse or are they single-use devices? Why does this matter?
The EZ STEER THERMOCOOL CATHETERS are supplied sterile for **single-use only**. This is important because single-use devices eliminate the risk of cross-contamination between patients, which is critical in sterile cardiac ablation procedures. Reusing medical devices in this context could introduce infection risks, so adherence to single-use guidelines ensures patient safety and procedural integrity.
What specific RF generator system must be used with these catheters, and why is compatibility important?
These catheters are **intended for use exclusively with the Stockert 70 RF Generator System**. Compatibility is critical because the generator controls the delivery of radiofrequency energy, which must be precisely calibrated for safe and effective cardiac ablation. Mismatched systems could lead to improper lesion formation, reduced efficacy, or even procedural complications.
How are the catheters stored, and what precautions should be taken before use?
Storage instructions are detailed in the **accompanying instructions for use**, though the data does not specify exact conditions. Generally, for sterile, single-use devices like these, storage should be in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, verify the sterile packaging is intact and follow aseptic techniques to prevent contamination, as these catheters are designed for percutaneous (skin-entry) procedures in electrophysiology labs.
What types of arrhythmias are these catheters intended to treat, and how does the deflectable tip help?
While the exact arrhythmias aren’t listed, these catheters are **designed for cardiac ablation procedures** to treat arrhythmias by creating controlled tissue lesions in the heart. The **deflectable tip** allows for precise navigation within cardiac chambers, enabling clinicians to target specific areas—such as abnormal pathways or foci—with greater accuracy, improving the likelihood of successful ablation and reducing risks like perforation or incomplete lesion formation.
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. Sources consulted: Johnson & Johnson Biosense Webster EZ STEER THERMOCOOL NAV Instructions ..., PDF Far-Reaching Effects - Biosense Webster, Johnson & Johnson Biosense Webster EZ STEER THERMOCOOL NAV Manuals, EZ STEER - Biosense Webster - PDF Catalogs - MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990071 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA PMA P990071 24 fields · synced Sep 18, 2026