Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 24426 [2013-09744]
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24426
Federal Register / Vol. 78, No. 80 / Thursday, April 25, 2013 / Notices
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collections of information in 21 CFR
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OMB control number 0910–0338.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
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and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
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Dated: April 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09759 Filed 4–24–13; 8:45 am]
BILLING CODE 4160–01–P
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.
tkelley on DSK3SPTVN1PROD with NOTICES
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 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.
VerDate Mar<15>2010
17:22 Apr 24, 2013
Jkt 229001
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,
Sara.Anderson@fda.hhs.gov, 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 https://
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
the meeting. Background material is
available at https://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
Annmarie.Williams@fda.hhs.gov 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
https://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
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 78, Number 80 (Thursday, April 25, 2013)]
[Notices]
[Page 24426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09744]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
Sara.Anderson@fda.hhs.gov, 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 https://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 https://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
Annmarie.Williams@fda.hhs.gov 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 https://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
