VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump)
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- nGEN Pump EUDAMEDTRUPULSE Generator EUDAMEDVARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) FDA PMA
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation FDA PMA
- Device Name
- nGEN Pump EUDAMEDTRUPULSE Generator EUDAMED
- Model / Reference
- nGEN Pump EUDAMEDD139701 EUDAMEDTRUPULSE EUDAMEDD141701 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10846835017458 EUDAMED10846835025231 EUDAMED
- Basic UDI-DI
- 08453840a0014CW EUDAMED08468350a0037FC EUDAMED
- Direct Marketing DI
- 10846835017458 EUDAMED10846835025231 EUDAMED
- PMA Number
- P240006 FDA PMA
- FDA Product Code
- QZI FDA PMA
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMEDZ12059011 CARDIAC ABLATION EQUIPMENT EUDAMED
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass III FDA PMA
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The VARIPULSE Platform is a percutaneous cardiac ablation system designed for cardiac electrophysiological mapping and the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation in adults. The system consists of the VARIPULSE Catheter, which provides location information when used with the CARTO 3 System, the TRUPULSE Generator for delivering pulsed field ablation, the nGEN Pump for irrigation, and a Sterile Interface Cable.
This device is intended for use in adults 22 years of age and older during cardiac ablation procedures. The Sterile Interface Cable may be reused following specific cleaning and sterilization protocols as detailed in the instructions for use. The platform has received FDA PMA authorization for its indicated clinical applications.
Frequently asked questions
What is the primary clinical use of the VARIPULSE Platform?
The platform is indicated for cardiac electrophysiological mapping and the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation in adult patients 22 years and older.
Can the Sterile Interface Cable be reused?
Yes, the Sterile Interface Cable is designed to be reusable, provided that the user adheres to the specific cleaning and sterilization restrictions outlined in the device's instructions for use.
Does the VARIPULSE Catheter provide location data?
Yes, the VARIPULSE Catheter is designed to provide location information when it is used in conjunction with the CARTO 3 System.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TRUPULSE Generator; Sterile Interface Cable; nGEN Pump ..., VARIPULSE™ Platform | Biosense Webster - J&J MedTech, Biosense Webster Updates Use Instructions for Varipulse - FDA, TRUPULSE™ Generator; Sterile Interface Cable ... - Innolitics, HaRi · VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P240006 | Class III | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (3)
- FDA PMA P240006 23 fields · synced Sep 18, 2026
- EUDAMED e3288ef6-8f81-45de-b56d-0729196311a8 61 fields · synced Jul 13, 2026
- EUDAMED ce27335f-19e0-457f-a986-2cd25d9fa3db 61 fields · synced Jul 13, 2026