Pulsed Field Ablation System (PFA)

75F40126Q00391

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

Posted: Aug 25, 2026

Due: Sep 3, 2026, 6:30 PM(9 days)

Last Updated: Aug 25, 2026

Key Requirements

Response Deadline

Sep 3, 2026, 6:30 PM(EDT)9 days

Eligibility

NONE

Contract Type

Solicitation

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.

Points of Contact

Primary Contact

Iris Johnson

Iris.Johnson1@fda.hhs.gov

3017963353

Organization Details

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

FDA OFFICE OF ACQ GRANT SVCS

11601 Landsdown St

Floor 13

Rockville, MD, 20852

Classifications

NAICS

334510

Electromedical and Electrotherapeutic Apparatus Manufacturing

31-33├Manufacturing

334├Computer and Electronic Product Manufacturing

3345├Navigational, Measuring, Electromedical, and Control Instruments Manufacturing

33451├Navigational, Measuring, Electromedical, and Control Instruments Manufacturing

334510└Electromedical and Electrotherapeutic Apparatus Manufacturing

PSC

6515

MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

65├MEDICAL/DENTAL/VETERINARY EQPT/SUPP

6515└Medical and Surgical Instruments, Equipment, and Supplies

Set-Aside

NONE

No Set aside used

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