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Solicitation

Pulsed Field Ablation System (PFA)

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

No Set aside usedNAICS 334510PSC 6515Amended
Response deadlineSep 3, 2026
PostedAug 25, 2026
Solicitation75F40126Q00391
Notice IDdf2b9477499441e0aeca62280295bb72
Notice typeSolicitation
Set-asideNo Set aside used
Place of performance
AwardNot posted

Notice description

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.

Notice and amendment history

Attachments

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