SOLICITATION NOTICE
65 -- Pulsed Field Ablation System (PFA)
- Notice Date
- 8/25/2026 12:00:00 AM
- Notice Type
- Solicitation
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- FDA OFFICE OF ACQ GRANT SVCS Rockville MD 20852 USA
- ZIP Code
- 20852
- Solicitation Number
- 75F40126Q00391
- Response Due
- 9/3/2026 11:30:00 AM
- Archive Date
- 09/18/2026
- Point of Contact
- Iris Johnson, Phone: 3017963353
- E-Mail Address
-
Iris.Johnson1@fda.hhs.gov
(Iris.Johnson1@fda.hhs.gov)
- Small Business Set-Aside
- NONE No Set aside used
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/workspace/contract/opp/df2b9477499441e0aeca62280295bb72/view)
- Record
- SN07943001-F 20260827/260825230049 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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