Identity
- Trade Name
- Volt PFA System FDA PMA
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation FDA PMA
Identifiers
- PMA Number
- P250022 FDA PMA
- FDA Product Code
- QZI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Volt PFA System is a Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation, designed to deliver pulsed field ablation (PFA) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent atrial fibrillation. This catheter-based approach uses high-intensity, short-duration electrical pulses to create irreversible electroporation in cardiac tissue, effectively isolating arrhythmogenic foci. It is intended for use in conjunction with a compatible PFA generator and the EnSite X EP System for precise mapping and ablation guidance.
The Volt PFA System is supplied as a reusable catheter (Sensor Enabled) paired with the Current PFA Generator, both of which are regulated under FDA_PMA (PMA Number: P250022). The catheter is compatible with the EnSite X EP System for electroanatomical mapping and is intended for use in electrophysiology laboratories by trained clinicians. No specific sterility or single-use designation is noted; however, standard sterile techniques must be followed during procedure preparation. The system is classified as Class III under FDA regulations and is not indicated for MRI use.
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 | P250022 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P250022 23 fields · synced Sep 18, 2026