Procure one pulsed field ablation (PFA) system, including generator, compatible catheters, required accessories/cables, training, warranty, and technical support.

Active Purchase Order Awarded Last action

Contract number
75F40126P00408
Awardee
Awarding agency
Obligated
$184,720

Award facts

Opportunity
Contract value 100% obligated
$184,720.00 Current and potential, with all options
Completion date 7% complete
Current and potential, with all options
Contracting staff
NAICS code
334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
PSC
6515 Medical And Surgical Instruments, Equipment, And Supplies
Set-aside
No set-aside
Competition
Competed under SAP · 2 offers Simplified Acquisition
Pricing
Firm Fixed Price
Place of performance
Irvine, CA 92618, USA

Award details come from SAM.gov/FPDS.

About this award

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.

Quick answers

Who was awarded contract 75F40126P00408?

75F40126P00408 was awarded to Biosense Webster, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 28, 2026.

How much is contract 75F40126P00408 worth?

The government has obligated $184,720 on 75F40126P00408.

Was contract 75F40126P00408 competed?

The extent of competition for 75F40126P00408 was competed under sap. The government received 2 offers.

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