[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Page 24426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09744]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0293]
Orthopaedic and Rehabilitation 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: 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 24 and 25, 2013,
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 20877. The hotel telephone
number is 301-977-8900.
Contact Person: Sara J. Anderson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, 301-796-7047,
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On July 24, 2013, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Kineflex/C Cervical Artificial Disc
sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt
chrome molybdenum alloy) cervical total disc replacement device. The
Kineflex/C is indicated for reconstruction of the intervertebral disc
at one level from C3-C7 following single-level discectomy for
intractable radiculopathy or myelopathy due to a single-level
abnormality localized to the disc space.
On July 25, 2013, the committee will discuss, make recommendations,
and vote on information related to the premarket approval application
for the Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The
Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome
molybdenum alloy) lumbar total disc replacement device. The Kineflex
Lumbar Artificial Disc is indicated for reconstruction of the
intervertebral disc at one level (L4-L5 or L5-S1) following single-
level discectomy for lumbar degenerative disc disease (DDD) where DDD
is defined as discogenic back pain with degeneration of the disc as
confirmed by patient history, physical examination, and radiographic
studies.
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 meeting
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
15, 2013. Oral presentations from the public will be scheduled on July
24 and 25, 2013, between approximately 11:30 a.m. and 12:30 p.m. 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 July
5, 2013. 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 8, 2013.
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 at
[email protected] or 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: April 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-09744 Filed 4-24-13; 8:45 am]
BILLING CODE 4160-01-P