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Pulsed Field Ablation System (PFA)

HEALTH AND HUMAN SERVICES, DEPARTMENT OF.FOOD AND DRUG ADMINISTRATION.FDA OFFICE OF ACQ GRANT SVCS

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Posted
Aug 26, 2026
Closes
Sep 3, 2026 (in 8 days)

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At a glance

This is a government contract opportunity posted by HEALTH AND HUMAN SERVICES, DEPARTMENT OF in the electromedical and electrotherapeutic apparatus manufacturing category. The deadline is September 3, 2026, 9 days from now.

Classification and identifiers

Industry (NAICS)
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
Product or service (PSC)
Medical and Surgical Instruments, Equipment, and Supplies (6515)
Solicitation number
75F40126Q00391

Who can apply

Location not specified

About this opportunity

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.

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