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Advisory Committee Meeting | Virtual

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

Date:
December 3, 2025
Time:
9:00 a.m. - 6:00 p.m. ET

What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Webcast Information:

YouTube:

https://youtu.be/BrfPZmnypXs

CenterDateTimeLocation
CDRHDecember 3, 20259:00 a.m. - 6:00 p.m.Virtual

SUMMARY:  

The Food and Drug Administration (FDA) announces a forthcoming virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on the FDA’s regulatory issues.  

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 meeting will be open to the public. The FDA is establishing a docket for public comment.

DATES:  

The meeting will be held virtually on December 3, 2025, from 9 a.m. to 6 p.m. ET.

ADDRESSES:  

Answers to commonly asked questions about FDA advisory committee meetings, may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.  

PUBLIC COMMENT:  

The FDA is establishing a docket for public comment on this meeting. The docket number is 2025-19762. The docket will close on January 3, 2026. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.  

Comments received on or before November 14, 2025, will be provided to the Committee. Comments received after that date will be taken into consideration by the FDA. In the event that the meeting is cancelled, the FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.

Individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 10, 2025. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, the FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 13, 2025.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

Event Materials

Title File Type/Size Source Organization
Circulatory Devices December 3, 2025 Webcast Link pdf (200.74 KB)
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