Pulsed Field Ablation (PFA) System for Non-Clinical Research Use
The FDA is conducting market research via a Sources Sought Notice 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 treating atrial fibrillation or other cardiac arrhythmias. This notice is not a solicitation and does not commit the government to issue an award. Interested vendors must submit the required Vendor Response Form and supporting capability information by the response deadline stated in the posting.