Stratvocate offers a wealth of information and easy-to-use tools for those involved in federal contracting.

Subject: Pulsed Field Ablation System (PFA)
Solicitation Number: 75F40126Q00391
Notice Type: SOLICIT
NAICS: 334510
Set-Aside: No Set aside used
Notice Published: 08-25-26
Response Due: 09-03-26

Agency: Department of Health and Human Services
Office: FOOD AND DRUG ADMINISTRATION
Contact: Iris Johnson This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: (301) 796-3353
Office Address: Rockville, MD 20852



Click for official SAM (FBO) notice, additional information, and accompanying attachments

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.