Identity
- Trade Name
- IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR FDA PMA
- Generic Name
- Cardiac ablation percutaneous catheter FDA PMA
Identifiers
- PMA Number
- P040014 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 IBI Therapy Cardiac Ablation System is a Cardiac Ablation Percutaneous Catheter, designed for electrophysiological mapping and radiofrequency (RF) ablation procedures. It is intended for interrupting accessory atrioventricular (AV) conduction pathways associated with tachycardia, treating AV nodal re-entrant tachycardia (AVNRT), or creating complete AV nodal block in select patients with uncontrolled ventricular responses to atrial arrhythmias.
This system is used in electrophysiology laboratories under sterile conditions, typically in conjunction with a compatible RF generator (e.g., ERS/1500T). It is a reusable device, classified as Class III under FDA regulations, and holds a PMA approval (P040014). The system includes diagnostic and therapeutic catheters for mapping cardiac electrophysiology and delivering targeted RF energy to endocardial structures. No specific MRI safety or single-use designation is noted in the regulatory data.
Frequently asked questions
What specific types of heart arrhythmias is the IBI Therapy Cardiac Ablation System designed to treat, and how does it work?
The IBI Therapy Cardiac Ablation System is designed to treat accessory atrioventricular (AV) conduction pathways causing tachycardia, AV nodal re-entrant tachycardia (AVNRT), and to create a complete AV nodal block in patients with uncontrolled ventricular responses to atrial arrhythmias. It works by using diagnostic and therapeutic catheters to map cardiac electrophysiology and deliver targeted radiofrequency (RF) energy to specific endocardial structures, effectively interrupting abnormal electrical pathways.
Is the IBI Therapy Cardiac Ablation System intended for single-use or reusable applications, and how should it be handled?
The IBI Therapy Cardiac Ablation System is a reusable device. Since it is used in sterile electrophysiology laboratories, proper cleaning, sterilization, and maintenance procedures must be followed between uses to ensure safety and functionality. The system requires compatibility with a compatible RF generator, such as the ERS/1500T, for operation.
What types of catheters are included in the IBI Therapy Cardiac Ablation System, and how are they used?
The system includes diagnostic catheters for mapping cardiac electrophysiology and therapeutic catheters for delivering targeted radiofrequency (RF) energy. These catheters are used to identify abnormal electrical pathways in the heart and then apply controlled RF energy to disrupt those pathways, helping to restore normal heart rhythm during procedures like ablation for tachycardia.
What regulatory approval does the IBI Therapy Cardiac Ablation System hold, and what does this mean for its use?
The IBI Therapy Cardiac Ablation System holds a **PMA approval (P040014)** from the FDA, which means it has undergone rigorous review and is classified as a Class III device. This approval confirms its safety and effectiveness for its intended uses, including mapping and RF ablation for specific arrhythmias, and ensures it meets strict manufacturing and performance standards before being used in clinical settings.
Does the IBI Therapy Cardiac Ablation System require any specific equipment to operate, and what are the key considerations for its use?
Yes, the system requires a compatible RF generator, such as the ERS/1500T, to deliver the controlled radiofrequency energy needed for ablation procedures. Key considerations include ensuring proper sterile conditions in the electrophysiology lab, using the correct catheters for mapping and ablation, and following manufacturer guidelines for setup, operation, and maintenance to ensure safe and effective treatment of targeted arrhythmias.
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: Ibi Therapy Cardiac Ablation System Ers/ 1500t Rf Generator (P040014 ..., PDF Irvine Biomedical; Therapy Cardiac Ablation System; P040014 Irvine ..., THERAPY CARDIAC ABLATION SYSTEM (UDI: P040014) Specs & FDA Data
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040014 | Class III | Active |
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Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.
Sources (1)
- FDA PMA P040014 24 fields · synced Sep 18, 2026