PMA P250022S001

Device: Volt PFA Catheter Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P250022
Supplement: S001
Product code: QZI
Decision date: 2026-03-23
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
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.

Current openFDA PMA Record#

Device: Volt PFA Catheter Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P250022
Supplement: S001
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-03-23
Decision code: APPR
Date received: 2025-12-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.