PMA P240006

Device: VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)
Applicant: Biosense Webster, Inc.
Product code: QZI
Decision date: 2026-02-12
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Approval order statement: approval of the protocol updates to align with the PMA approval and to satisfy Central IRB requirements and justify revision of the inclusion criterion

Current openFDA PMA Record#

Device: VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)
Applicant: Biosense Webster, Inc.
PMA number: P240006
Supplement: S014
Product code: QZI
Generic name: Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Decision date: 2026-02-12
Decision code: APPR
Date received: 2025-11-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the protocol updates to align with the PMA approval and to satisfy Central IRB requirements and justify revision of the inclusion criterion