PMA P230030S021

Device: FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,
Applicant: Farapulse, Inc.
PMA number: P230030
Supplement: S021
Product code: QZI
Decision date: 2026-06-05
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: addition of a supplier for a catheter subcomponent

Current openFDA PMA Record#

Device: FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,
Applicant: Farapulse, Inc.
PMA number: P230030
Supplement: S021
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-06-05
Decision code: OK30
Date received: 2026-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a supplier for a catheter subcomponent