November 4, 2009: Orthopaedic and Rehabilitation Devices Panel Meeting Announcement

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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: Orthopaedic and Rehabilitation 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 November 4, 2009, from 

8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/Whetstone Room, Two Montgomery Village
Ave., Gaithersburg, MD.

Contact Person: Ronald P. Jean, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD, 20993, 301–796–5650, or FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code
3014512521. 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 November 4, 2009, the committee will discuss, make
recommendations and vote on a premarket approval application for the
Dynesys Spinal System, sponsored by Zimmer Spine. The Dynesys Spinal
System is indicated to provide spinal alignment and stabilization in skeletally
mature patients at one or two contiguous levels from L1–S1.
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 on the FDA Internet
under the appropriate date 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 October 28, 2009.
Oral presentations from the public will be scheduled between approximately
1 p.m. and 2 p.m. 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 October 20, 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 October 21,
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 Ann Marie 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: 10/1/09.
David Horowitz,
Assistant Commissioner for Policy.