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  4. ›Pulsed Field Ablation System (PFA)

U.S. Department Of Health And Human Services·Maryland

Pulsed Field Ablation System (PFA)

Closes 9/3/2026$150k – $600kRequest for Quotation
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Description

The FDA’s Center for Devices and Radiological Health seeks a single, off‑the‑shelf Pulsed Field Ablation (PFA) system for non‑clinical research. The award will include a PFA generator, five clinical‑grade catheters, all accessories, software licenses, setup/start‑up assistance, functional testing, training, a minimum 12‑month warranty, and ongoing technical support. Delivery must occur within 30 calendar days to the FDA office in Silver Spring, MD, with training completed within 15 business days after delivery. The contract will be awarded on a Lowest Price Technically Acceptable (LPTA) basis. • One complete PFA system (generator + 5 catheters) for research use • Includes accessories, cables, connectors, software/licenses, and warranty • Delivery within 30 days FOB destination to Silver Spring, MD • Setup, functional testing, and training required before acceptance • 12‑month warranty; possible administrative extensions after award • Evaluation: technical compliance (pass/fail) + lowest evaluated price • Questions due 27 Aug 2026; offers due 3 Sep 2026

Attached files

Contact

Iris Johnson(Contracting Officer)

[email protected]

(301) 796-3353

Key dates

Opened
8/25/2026
Questions due
8/27/2026
Closes
9/3/2026
Duration
12 months

Last updated

Details

Type
Request for Quotation
Industry
Healthcare and Medical Services
NAICS
334510
Solicitation №
75F40126Q00391

Budget estimate

$150,000 – $600,000

The solicitation does not disclose a contract value. A commercial PFA system with generator, five clinical catheters, accessories, software licenses, training, and a 12‑month warranty typically ranges from $200,000 to $500,000 depending on brand, configuration, and support level. Accounting for possible premium for rapid delivery and full‑service support, a reasonable estimate is $150,000 on the low end to $600,000 on the high end.

AI estimate from the solicitation

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