Advisory Committees

July 27, 2010: Orthopaedic and Rehabilitation Devices Panel Meeting Notice

Food and Drug Administration
[Docket No. FDA–2010–N–0001]
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 July 27, 2010, from 8 a.m.
to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Tracy Phillips, Food and Drug Administration, Center for
Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm.
1611, Silver Spring, MD 20993–0002, 301–796–6150 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 July 27, 2010, the committee will discuss, make
recommendations and vote on a premarket approval application for the
AMPLIFY rhBMP-2 Matrix, sponsored by Medtronic, Inc. The AMPLIFY
rhBMP-2 Matrix is used for posterolateral fusion treatment of single level
lumbar (L2–S1) degenerative disc disease.
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
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 July 21, 2010.
Oral presentations from the public will be scheduled between approximately
1 and 2 p.m., immediately following lunch. 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 July 13,
2010. 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 July 14, 2010.

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
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: June 18, 2010.
Thinh Nguyen,
Acting Associate Commissioner for Special Medical Programs.

Page Last Updated: 08/12/2015
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