Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 40277 [2023-13136]
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Federal Register / Vol. 88, No. 118 / Wednesday, June 21, 2023 / Notices
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.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:36 Jun 20, 2023
Jkt 259001
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
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
40277
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/Advisory
Committees/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–NEW]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
