| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Volt™ PFA System |
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| Generic Name | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation |
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| Applicant | ABBOTT MEDICAL
5050 Nathan Ln. N.
Plymouth, MN 55442 |
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| PMA Number | P250022 |
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| Date Received | 06/27/2025 |
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| Decision Date | 12/19/2025 |
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| Product Code |
QZI |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT06223789
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
approval for the Volt™ PFA System. This device is indicated for: The Volt™ PFA Catheter, Sensor Enabled™ is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal or persistent (episode duration less than one year) atrial fibrillation when used in conjunction with a compatible pulsed field ablation (PFA) generator. The catheter is compatible with the EnSite™ X EP System. The Current™ PFA Generator is indicated for use with compatible ablation catheters for the treatment of cardiac arrhythmias. |
| Approval Order | Approval Order |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S003 S004 S006 S007 |
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