Pulsed Field Ablation System (PFA)

The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), has a requirement for one complete, off-the-shelf Pulsed Field Ablation (PFA) system for use in a non-clinical research environment. The required system includes a PFA generator, five compatible clinical PFA catheters, all required accessories, cables, connectors, applicable software and licenses, setup/startup assistance, functional testing, training, warranty coverage, and technical support, in accordance with Attachment 1 – Statement of Work (SOW). Questions are due Thursday, August 27, 2026, at 10:30 a.m. ET. Offers are due Thursday, September 3, 2026, at 2:30 p.m. ET.

• NAICS334510
• PSC6515

• Attachment 1_SOW_CDRH-2026-134633.pdf

  .pdf137 KBNot yet available
• Solicitation_CDRH-2026-134633.pdf

  .pdf306 KBNot yet available

• Iris Johnson
  iris.johnson1@fda.hhs.gov3017963353