PMA P240013

Device: Affera Ablation System
Applicant: Medtronic, Inc.
Product code: QZI
Decision date: 2026-05-28
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: approval for minor labeling updates to the Affera Ablation System User Manual to reflect expanded connectivity options on the modified Affera System Cart

Current openFDA PMA Record#

Device: Affera Ablation System
Applicant: Medtronic, Inc.
PMA number: P240013
Supplement: S022
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-05-28
Decision code: APPR
Date received: 2026-02-27
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for minor labeling updates to the Affera Ablation System User Manual to reflect expanded connectivity options on the modified Affera System Cart