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  4. August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 08/22/2023
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Advisory Committee Meeting | Virtual

Event Title
August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
August 22 - 23, 2023


Date:
August 22 - 23, 2023
Time:
9:00 AM - 6:00 PM 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:

August 22, 2023 - Day 1 WebCast Link
YOUTUBE (primary): https://youtu.be/Guz-BWP6cQc 
TEAMS (captions): https://teams.microsoft.com/day1

August 23, 2023 - Day 2 WebCast Link
YOUTUBE (primary): https://youtu.be/Gb2UZPVCgms
TEAMS (captions): https://teams.microsoft.com/day2

Center Date Time Location
CDRH August 22, 2023
August 23, 2023
9:00 a.m. - 6:00 p.m.
9:00 a.m. - 6:00 p.m.
 All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.    

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

[Docket No. FDA-2023-N-0008] 

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee.  The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open to the public.

DATES:  The meeting will take place virtually on August 22 and 23, 2023, from 9 a.m. to 6 p.m. Eastern Time. 

ADDRESSES:  All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.  Answers to commonly asked questions, including information regarding special accommodations due to a disability, may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.  

FOR FURTHER INFORMATION CONTACT:  Jarrod Collier, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, Jarrod.Collier@fda.hhs.gov, 240-672-5763, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).  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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting.

SUPPLEMENTARY INFORMATION:

Agenda:  The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform.  On both days, the committee will discuss, make recommendations, and vote on devices indicated to reduce blood pressure in patients with hypertension.  On August 22, 2023, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the ReCor Paradise Ultrasound Renal Denervation System by ReCor, Inc.  The proposed indication for use statement is as follows:  The ReCor Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure in adult (≥ 22 years of age) patients with uncontrolled hypertension, who may be inadequately responsive to, or who are intolerant to, antihypertensive medications, which is intended to be used in renal arteries of diameters ranging from 3.0 to 8.0 mm.  

On August 23, 2023, the committee will discuss, make recommendations, and vote on information regarding the PMA for the Medtronic Symplicity Spyral Renal Denervation System by Medtronic, Inc.  The proposed indication for use statement is as follows:  The Symplicity Spyral multielectrode renal denervation catheter and the Symplicity G3 RF Generator are indicated for the reduction of blood pressure in patients with uncontrolled hypertension despite the use of antihypertensive medications or in patients in whom blood pressure lowering therapy is poorly tolerated.

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.  Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.  Scroll down and select the appropriate advisory committee meeting link.  The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure:  Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before August 1, 2023.  Oral presentations from the public will be scheduled on August 22 and 23, 2023 between approximately 1:30 p.m. and 2:30 p.m. Eastern Time.  Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT) 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 July 24, 2023.  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, 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 July 25, 2023.  

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

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 Ann Marie Williams at AnnMarie.Williams@fda.hhs.gov or 240-507-6496 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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).

Dated:  June 12, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.


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
CSDP Aug. 22-23, 2023 Waiver (Lewis) pdf (272.74 KB)
CSDP Aug. 22-23, 2023 Waiver (Nachman) pdf (266.49 KB)
CSDP Aug. 22-23, 2023 Waiver (Starling) pdf (271.57 KB)
CSDP Aug. 22-23, 2023 Waiver (Yeh) pdf (276.52 KB)
CSDP Aug. 22-23, 2023 Waiver Acknowledgement (Lewis) pdf (182.50 KB)
CSDP Aug. 22-23, 2023 Waiver Acknowledgement (Nachman) pdf (185.51 KB)
CSDP Aug. 22-23, 2023 Waiver Acknowledgement (Starling) pdf (180.97 KB)
CSDP Aug. 22-23, 2023 Waiver Acknowledgement (Yeh) pdf (181.84 KB)
CSDP August 22, 2023 Agenda pdf (115.27 KB)
CSDP August 22, 2023 FDA Questions pdf (529.89 KB)
CSDP August 22, 2023 FDA Voting Questions pdf (118.93 KB)
CSDP August 22, 2023 Roster pdf (299.63 KB)
CSDP August 22, 2023 FDA Executive Summary pdf (3.35 MB)
CSDP August 22, 2023 Appendix 1 - FDA Executive Summary Dec. 5, 2018 pdf (1.85 MB)
CSDP August 22, 2023 Appendix 2 - 24 Hour Summary Dec.5, 2018 pdf (71.00 KB)
CSDP August 22, 2023 Sponsor Executive Summary pdf (4.21 MB)
CSDP August 22, 2023 Appendix 4 - Sponsor Supplemental Clinical Data pdf (563.52 KB)
CSDP August 23, 2023 Agenda pdf (116.67 KB)
CSDP August 23, 2023 Roster pdf (299.62 KB)
CSDP August 23, 2023 FDA Questions pdf (735.96 KB)
CSDP August 23, 2023 FDA Voting Questions pdf (119.30 KB)
CSDP August 23, 2023 FDA Executive Summary pdf (11.70 MB)
CSDP August 23, 2023 Sponsor Executive Summary pdf (19.31 MB)
CSDP August 23, 2023 Appendix 1 - FDA Executive Summary Dec. 5, 2018 pdf (1.85 MB)
CSDP August 23, 2023 Appendix 2- 24 Hour Summary Dec. 5, 2018 pdf (72.38 KB)
CSDP August 23, 2023 Sponsor Bayesian Method pdf (217.50 KB)
CSDP August 23, 2023 Appendix 5 - Additional Clinical Data pdf (312.88 KB)
CSDP August 22, 2023 Errata to Sponsor Briefing Document pdf (501.58 KB)
CSDP August 22, 2023 Errata to Sponsor Briefing Document pdf (132.31 KB)
CSDP Aug. 22, 2023 24 Hour Summary pdf (241.77 KB)
CSDP Aug. 22, 2023 Sponsor Presentation pdf (3.08 MB)
CSDP Aug. 22, 2023 FDA Presentation pdf (2.81 MB)
CSDP Aug. 23, 2023 24 Hour Summary pdf (229.48 KB)
CSDP Aug. 23, 2023 FDA Presentation pdf (2.66 MB)
CSDP Aug. 23, 2023 Sponsor Presentation pdf (2.82 MB)
CSDP Aug. 22, 2023 Summary Minutes pdf (349.70 KB)
CSDP Aug. 23, 2023 Summary Minutes pdf (418.10 KB)
CSDP Aug. 22, 2023 Transcript pdf (1,023.83 KB)
CSDP Aug. 23, 2023 Transcript pdf (929.39 KB)

 
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