Solicitation
Pulsed Field Ablation System (PFA)
75F40126Q00391
Food and Drug Administration, FDA Office of Acq Grant SVCS. Electromedical and Electrotherapeutic Apparatus Manufacturing.
Awarded
$184,720.00 obligated so far on USAspending
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This one was awarded in 2026
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Description
As published on SAM.gov.
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
Files listed on SAM.gov. The ones we hold a copy of download from here; the rest open SAM's download, which needs no account.
- Solicitation_CDRH-2026-134633.pdf306 KB, August 25, 2026
The contract, on USAspending
Federal procurement data the awarding office reported to FPDS, matched to this solicitation by its number.
- Recipient
- Biosense Webster, Inc.
- UEI
- LU6KBGZ1A362
- CAGE
- 1LXW3
- Vendor location
- Irvine, CA
- Contract
- 75F40126P00408, purchase order
- Obligated
- $184,720.00
- Actions
- 1 between September 26, 2026 and September 26, 2026
- Competition
- Competed Under SAP, 2 offers received
- Set-aside reported
- No Set Aside Used.
- Described as
- Procure One Pulsed Field Ablation (Pfa) System, Including Generator, Compatible Catheters, Required Accessories/Cables, Training, Warranty, and Technical Support.
- Match
- solicitation number 75F40126Q00391 equals the FPDS solicitation identifier; same awarding office 75F401 (high confidence)
- Record
- USAspending award page
Publications
Every notice SAM.gov issued under this solicitation number, oldest first. Each is a separate record on SAM.
August 25, 2026
Solicitation
Due September 3, 2026 at 2:30 PM EDT. SAM.gov, notice df2b9477499441e0aeca62280295bb72
1 revisions on SAM
- August 25, 2026: publish, solicitation
Points of contact
- Iris JohnsonIris.Johnson1@fda.hhs.gov3017963353