PMA P230030

Device: FARAPULSE™ Pulsed Field Ablation System
Applicant: Farapulse, Inc.
Product code: QZI
Decision date: 2026-05-06
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization

Current openFDA PMA Record#

Device: FARAPULSE™ Pulsed Field Ablation System
Applicant: Farapulse, Inc.
PMA number: P230030
Supplement: S019
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-05-06
Decision code: OK30
Date received: 2026-04-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the extension of maximum transfer time between preconditioning cell to sterilization chamber during routine production for Ethylene Oxide(EtO) sterilization