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This Solicitation opportunity from Department Of Health And Human Services was posted on August 25, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Pulsed Field Ablation System (PFA)

Closed
75F40126Q00391Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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AI Contract Overview

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The U.S. Food and Drug Administration Center for Devices and Radiological Health is soliciting quotations under solicitation 75F40126Q00391 for one complete, off-the-shelf Pulsed Field Ablation system for use in a non-clinical research environment. The requirement includes a new, current-production PFA generator, five compatible clinical PFA catheters of the same model and configuration, all necessary accessories, cables, connectors, and applicable software licenses. The contractor is responsible for providing setup and startup assistance, functional testing to ensure the system operates per manufacturer specifications, and training to be completed within 15 business days after delivery. The system must include a minimum 12-month manufacturer's standard commercial warranty and ongoing technical support. The contract will be awarded using the Lowest Price Technically Acceptable method, with technical acceptability determined on a pass/fail basis. A critical evaluation factor is the provision of hemolysis-related history, safety-profile discussions, and supporting documentation. Delivery is required within 30 calendar days after receipt of order to Silver Spring, Maryland, on a FOB Destination basis, with the contractor bearing all packing, shipping, and insurance costs. Offerors must submit two separate volumes, a technical volume containing a compliance matrix and product identification, and a price volume. Questions are due by August 27, 2026, and final offers are due by September 3, 2026.

General Info

FDA seeks Pulsed Field Ablation system and support under solicitation 75F40126Q00391.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contract Value

$184,720

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

MD

Set-Aside

NONE

Awardee

BIOSENSE WEBSTER, INC.

Award Issued Date

Documents

2

75F40126Q00391 RFQ - Pulsed Field Ablation System

PDF, High priority: read this firstrfq
High

ALP CDRH-2026-134633 SOW for Pulsed Field Ablation System

PDF, High priority: read this firstsow
High

AI Contract Breakdown

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Timeline

PhaseClosed
Posted

Solicitation

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeRockville, MD, 20852, USA
Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Office AddressRockville, MD, 20852, USA
Contacts
Iris Johnson
contact@example.gov
+1 (555) 000-0000

Full Description

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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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