PMA P250022

Device: Current™ PFA Generator – TactiFlex Duo
Applicant: ABBOTT MEDICAL
Product code: QZI
Decision date: 2026-07-23
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: approval for firmware updates for the Current™ PFA Generator and compatible accessories

Current openFDA PMA Record#

Device: Current™ PFA Generator – TactiFlex Duo
Applicant: ABBOTT MEDICAL
PMA number: P250022
Supplement: S005
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-07-23
Decision code: APPR
Date received: 2026-04-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for firmware updates for the Current™ PFA Generator and compatible accessories