PMA P230017S009

Device: PulseSelect™ Pulsed Field Ablation (PFA) system
Applicant: Medtronic, Inc.
PMA number: P230017
Supplement: S009
Product code: QZI
Decision date: 2026-02-17
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: the PulseSelect System for an update for R-wave gating of PulseSelect Pulsed Field Ablation (PFA) energy deliveries to be made optional

Current openFDA PMA Record#

Device: PulseSelect™ Pulsed Field Ablation (PFA) system
Applicant: Medtronic, Inc.
PMA number: P230017
Supplement: S009
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-02-17
Decision code: APPR
Date received: 2025-11-07
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: the PulseSelect System for an update for R-wave gating of PulseSelect Pulsed Field Ablation (PFA) energy deliveries to be made optional