The FDA awarded a purchase order to Biosense Webster, Inc. for one Pulsed Field Ablation system on September 28, 2026, with a ceiling value of $184,720.00.
The system, procured for the FDA's Center for Devices and Radiological Health at 10903 New Hampshire Avenue, Silver Spring, Maryland, comprises a PFA generator, five compatible clinical catheters, accessories, cables, software licenses, setup and startup assistance, functional testing, a manufacturer's standard twelve-month warranty, and technical support by telephone and email. Training must include at least one instructor-led session (in person or virtual) within fifteen business days of delivery covering system components, operation, safety, troubleshooting, and maintenance. The equipment must be FDA-approved or cleared for clinical use, new, unused, current production, and compatible with standard building power (115–120 volts, 60 hertz, single phase). Delivery is due within thirty calendar days of order receipt, FOB Destination. Performance of on-site activities is restricted to Monday–Friday, 6:30 a.m.–3:00 p.m. ET, excluding Federal holidays and facility closures. Ultimate completion date is November 19, 2027. The procurement originated from an FDA solicitation posted August 25, 2026, with offers due September 3, 2026, evaluated on Lowest Price Technically Acceptable basis.
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