| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Volt PFA Catheter Sensor Enabled™ |
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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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| Supplement Number | S001 |
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| Date Received | 12/23/2025 |
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| Decision Date | 03/23/2026 |
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| Product Code |
QZI |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | Yes |
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Approval Order 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. |
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