Document ID: FDA-2009-N-0664-0036
Agency: fda
Document Type: Notice
Title: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2009-04-28T04:00Z

[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19231-19232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9641]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

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 May 14, 2009, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Peter L. Hudson, Center for Devices and 
Radiological Health, (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3737, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information 
Line for up-to-date information on this meeting. A

[[Page 19232]]

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: The committee will discuss, make recommendations and 
vote on a premarket approval application for the DuraSeal Xact\TM\ 
Sealant System, sponsored by Confluent Surgical Inc. This device is 
indicated for use as an adjunct to sutured dural repair to obtain 
watertight closure during spinal surgery.
    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/ohrms/dockets/ac/acmenu.htm, click on the year 2009 and 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 
April 30, 2009. Oral presentations from the public will be scheduled 
for 30 minutes at the beginning of the committee deliberations and 
for 30 minutes near the end of the deliberations. Those desiring to 
make 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 April 28, 2009. 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 April 29, 2009.
    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. AnnMarie 
Williams, Conference Management Staff, at 240-276-8932, 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/oc/advisory/default.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: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9641 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S