Pulsed Field Ablation System (PFA)

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Federal
Type of Government: Federal
FSC Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
NAICS Category:
  • 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing
Set Aside: No Set aside used
Posted Date: Aug 25, 2026
Due Date: Sep 3, 2026
Solicitation No: 75F40126Q00391
Original Source: Please Login to View Page
Contact information: Please Login to View Page
Bid Documents: Please Login to View Page

Description

Follow
Pulsed Field Ablation System (PFA)
Active
Contract Opportunity
Notice ID
75F40126Q00391
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
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General Information
  • Contract Opportunity Type: Solicitation (Original)
  • Original Published Date: Aug 25, 2026 10:49 am EDT
  • Original Date Offers Due: Sep 03, 2026 02:30 pm EDT
  • Inactive Policy: 15 days after date offers due
  • Original Inactive Date: Sep 18, 2026
  • Initiative:
    • None
Classification
  • Original Set Aside: No Set aside used
  • Product Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES
  • NAICS Code:
    • 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing
  • Place of Performance:
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.


Attachments/Links
Contact Information
Contracting Office Address
  • 11601 Landsdown St Floor 13
  • Rockville , MD 20852
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Aug 25, 2026 10:49 am EDTSolicitation (Original)
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