Identity
- Trade Name
- HELIOS II ABLATION CATHETER FDA PMA
- Generic Name
- Cardiac ablation percutaneous catheter FDA PMA
Identifiers
- PMA Number
- P050029 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 Helios II Ablation Catheter is a cardiac ablation percutaneous catheter intended for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions to treat patients with supraventricular tachycardias (SVT). It is designed to eliminate atrioventricular reentrant tachycardia (AVRT) in patients with overt or concealed accessory pathways, AV nodal reentrant tachycardia (AVNRT), and to create complete AV nodal block in patients with difficult-to-control ventricular response to atrial fibrillation.
It is intended for use only with the Stereotaxis Magnetic Navigation System (MNS) and is compatible with the Biosense Webster Stockert 70 RF Generator via a Biosense Webster cable model C6-MR10/MSTK-S (6 foot) or C10-MR10/MSTK-S (10 foot). The device is supplied as a sterile, single-use catheter and is regulated under FDA PMA (P050029) as a Class III device.
Frequently asked questions
What is the Helios II Ablation Catheter used for?
The Helios II Ablation Catheter is intended for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions to treat patients with supraventricular tachycardias (SVT), including eliminating atrioventricular reentrant tachycardia (AVRT) in patients with overt or concealed accessory pathways, AV nodal reentrant tachycardia (AVNRT), and creating complete AV nodal block in patients with difficult-to-control ventricular response to atrial fibrillation.
What equipment is the Helios II Ablation Catheter compatible with?
The Helios II Ablation Catheter is intended for use only with the Stereotaxis Magnetic Navigation System (MNS) and is compatible with the Biosense Webster Stockert 70 RF Generator via a Biosense Webster cable model C6-MR10/MSTK-S (6 foot) or C10-MR10/MSTK-S (10 foot).
Is the Helios II Ablation Catheter reusable or single-use?
The Helios II Ablation Catheter is supplied as a sterile, single-use device, as indicated by its intended use and regulatory classification under FDA PMA for a percutaneous cardiac ablation catheter.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050029 | Class III | Active |
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Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA PMA P050029 24 fields · synced Sep 18, 2026