miércoles, 5 de noviembre de 2025

December 3, 2025: Circulatory System Devices Panel Advisory Committee Meeting Announcement December 3, 2025

https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-3-2025-circulatory-system-devices-panel-advisory-committee-meeting-announcement-12032025?utm_medium=email&utm_source=govdelivery FDA Announces Circulatory System Devices Panel Advisory Committee Meeting The U.S. Food and Drug Administration (FDA) announces a forthcoming virtual public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee (the Committee). On December 3, 2025, the Committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) sponsored by V-Wave, Inc. for the V-Wave Ventura Interatrial Shunt System, which is a first-of-a-kind device permanent implant designed to shunt blood from the left to the right atrium to improve symptoms in patients with advanced chronic heart failure. The virtual meeting will be open to the public. The FDA is establishing a docket for public comment. Registration is not required to attend the meeting.

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