Pulsed Field Ablation (PFA) System for Non-Clinical Research Use

The U.S. Food and Drug Administration is issuing this Sources Sought Notice for market research purposes to identify qualified sources capable of providing a complete, off-the-shelf Pulsed Field Ablation (PFA) system for non-clinical research use. The required system includes a PFA generator, compatible catheters, all necessary accessories and cables, on-site installation, startup and operational verification, training, documentation, warranty coverage, and technical support.

The proposed system must be FDA-approved or cleared for clinical use in the United States for the treatment of atrial fibrillation or other cardiac arrhythmias. This notice is not a solicitation and does not constitute a commitment by the Government to issue a solicitation or make an award. Interested vendors should review the attached Sources Sought Notice and submit the required Vendor Response Form and supporting capability information by the response deadline stated in the posting.