Document ID: FDA-2010-N-0001-0160
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2010-12-27T05:00Z

[Federal Register Volume 75, Number 247 (Monday, December 27, 2010)]
[Notices]
[Pages 81282-81283]
From the Federal Register Online via the Government Printing 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]
BILLING CODE 4160-01-P