Document ID: FDA-2011-N-0002-0010
Agency: fda
Document Type: Notice
Title: Meetings: Neurological Devices Panel of Medical Devices Advisory Committee
Posted Date: 2011-02-07T05:00Z

[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6625-6626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2574]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Neurological 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: Neurological 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 March 17 and 18, 2011, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C 
and D, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Olga Claudio, Food and Drug Administration, Center 
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 
66, rm. 1611, Silver Spring, MD, 301-796-7608, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), and follow the prompts to the desired center or 
product area. 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 March 17, 2011, the committee will discuss, make 
recommendations and vote on information related to the premarket 
approval application (PMA) for the NovoTTF-100A Treatment Kit, 
sponsored by Hogan Lovells US LLP for NovoCure, Ltd. The NovoTTF-100A 
Treatment Kit is intended as a treatment for adult patients (greater 
than 21 years of age) with histologically- or radiologically-confirmed 
glioblastoma multiforme (GBM), following recurrence in the supra-
tentorial region of the brain. The device is intended to be used as a 
monotherapy, after surgical and radiation options have been exhausted, 
in place of standard medical therapy for GBM. On March 18, 2011, the 
committee will discuss, make recommendations and vote on information 
related to the PMA for the Pipeline Embolization Device (PED), 
sponsored by Chestnut Medical. The PED is indicated for the 
endovascular treatment of large or giant wide-necked intracranial 
aneurysms in the paraclinoid region of the internal carotid artery.
    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 
March 10, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. immediately following lunch on 
March 17 and 18. 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 or before March 2, 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 March 3, 
2011.

[[Page 6626]]

    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 Ms. Ann Marie 
Williams, Conference Management Staff, at 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: February 1, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-2574 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P