[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Page 40277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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, 
[email protected], 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 
[email protected] 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 [email protected] 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 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


