Bid opportunityOpen

Pulsed Field Ablation System (PFA)

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

Response deadlineSep 3, 2026 2:30 PM EDT

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Key decision factors

Response deadline: Sep 3, 2026 2:30 PM EDT
Posted: Aug 25, 2026 12:00 AM EDT
Notice type: Solicitation
Set-aside: No Set aside used
NAICS: 334510
PSC: 6515
Place of performance: Not specified
Current status: Open

Notice details

Official status: Open
Normalized group: Bid opportunity
Notice ID: df2b9477499441e0aeca62280295bb72
Solicitation number: 75F40126Q00391

Description

Displayed as sanitized plain text from SAM.gov. Retrieved Aug 26, 2026 5:17 PM EDT.

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.

Attachments

2 attachments reported by SAM.gov

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Contacts

Iris Johnson

Primary

Iris.Johnson1@fda.hhs.gov

Phone: 3017963353

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