PMA P250022

Device: Volt™ PFA System
Applicant: ABBOTT MEDICAL
Product code: QZI
Decision date: 2026-10-15
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250022

Current openFDA PMA Record#

Device: Volt™ PFA System
Applicant: ABBOTT MEDICAL
PMA number: P250022
Supplement: S002
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-10-15
Decision code: APPR
Date received: 2026-01-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P250022