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Pulsed Field Ablation System (PFA)

Active

75F40126Q00391Federal

Response Deadline09/03/2026, 06:30:00 PM UTC

Contract Overview

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

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant SvcsView Agency

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus ManufacturingView NAICS

Place of Performance

MD

Set-Aside

NONE

Documents

(2)

Solicitation_CDRH-2026-134633.pdf

PDF

Attachment+1_SOW_CDRH-2026-134633.pdf

PDF

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Timeline

PhaseSolicitation

PostedAug 25

Solicitation

Response DeadlineSep 3

Submission deadline

Response Deadline

09/03/2026, 06:30:00 PM UTCin 9 days

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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 / Agency

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

View Agency Profile

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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