Notice2023-13136
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 118 (Wednesday, June 21, 2023)</title>
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[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Page 40277]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-13136]
[[Page 40277]]
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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.
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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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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,
<a href="/cdn-cgi/l/email-protection#fdb79c8f8f9299d3be92919194988fbd9b999cd395958ed39a928b"><span class="__cf_email__" data-cfemail="f3b99281819c97ddb09c9f9f9a9681b3959792dd9b9b80dd949c85">[email protected]</span></a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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
<a href="/cdn-cgi/l/email-protection#fa9c9e9b95979bba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="0f696b6e60626e4f696b6e2167677c21686079">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#266748484b47544f4308514f4a4a4f474b5566404247084e4e5508414950"><span class="__cf_email__" data-cfemail="55143b3b3834273c307b223c39393c343826153331347b3d3d267b323a23">[email protected]</span></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13136 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P
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