[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Pages 81282-81283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32367]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on January 25 and 26, 2011,
from 8 a.m. to 6 p.m.
Location: Holiday Inn, Main Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD. Information regarding special accommodations due to a
disability, visitor parking and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings.''
Please note that visitors to the White Oak Campus must enter through
Building 1.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 3014512625.
Please call the Information Line for up-to-date information on this
meeting. 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 Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On January 25, 2011, the committee will discuss and make
recommendations regarding regulatory classification of Automated
External Defibrillators to either reconfirm to class III (subject to
premarket approval application (PMA)) or reclassify to class II
(subject to premarket notification (510(k))), as directed by section
515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).
On January 26, 2011, the committee will discuss, make
recommendations and vote on information related to the PMA supplement
for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular.
The RX Acculink is indicated for treatment of patients at high and
standard risk for adverse events from carotid endarterectomy who
require carotid revascularization and meet the criteria outlined as
follows:
1. Patients with neurological symptoms and >50 percent stenosis of
the common or internal carotid artery or patients without neurological
symptoms and >80 percent (high risk) or >70 percent (standard risk)
stenosis of the common or internal carotid artery and
2. Patients must have a reference vessel diameter within the range
of 4.0 and 9.0 mm at the target lesion.
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 Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
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
January 18, 2011. Oral presentations from the public will be scheduled
for 1 hour at approximately 1 p.m., immediately following lunch on both
days. Those 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
[[Page 81283]]
or before January 10, 2011. 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 January
11, 2011.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, 301-796-5966, at least 7 days in advance
of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://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: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32367 Filed 12-23-10; 8:45 am]
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