PMA P240006S013

Device: VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump
Applicant: Biosense Webster, Inc.
PMA number: P240006
Supplement: S013
Product code: QZI
Decision date: 2026-01-02
Classification: Cardiovascular
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: the addition of an alternate supplier for a component used in the manufacture of the VARIPULSE Interface Cable

Current openFDA PMA Record#

Device: VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump
Applicant: Biosense Webster, Inc.
PMA number: P240006
Supplement: S013
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-01-02
Decision code: OK30
Date received: 2025-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of an alternate supplier for a component used in the manufacture of the VARIPULSE Interface Cable