Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Basic Information
- Device Name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Trade Name
- Volt PFA Catheter Sensor Enabled
- PMA Number
- P250022
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QZI
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 23, 2026
- Date Received
- December 23, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for minor design modifications, addition of Alajuela, Costa Rica as a manufacturing site, addition of Minnetonka, Minnesota as a basket subassembly manufacturing site, and addition of two Ethylene Oxide sterilization sites. Additionally, you requested approval for a Pre-Determined Change Control Plan (PCCP) that establishes updates to component suppliers for second source components for the balloon, splines, and center lumen of the catheter, provided they do not impact the specifications, the established methods for its sourcing, handling, and testing, or the qualification standards for supplier facilities and personnel for the devices under the above PMA.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | FDA class 3 | Unknown |