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
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