Pulsed Field Ablation System (PFA)
75F40126Q00391
The FDA's Center for Devices and Radiological Health requires the purchase of one complete, off-the-shelf Pulsed Field Ablation (PFA) system for use in a non-clinical research environment. The system must include a PFA generator, five compatible clinical PFA catheters, and all required accessories, cables, connectors, software, and licenses. The contract also includes setup and startup assistance, functional testing, training, warranty coverage, and technical support. All requirements must be delivered in accordance with the attached Statement of Work.