[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8326-8327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03155]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Orthopaedic and Rehabilitation 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 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 February 20, 2015, from
8 a.m. to 6 p.m.
Location: Hilton/Washington DC North, 620 Perry Pkwy.,
Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900.
Answers to commonly asked questions including information regarding
special accommodations due to a disability, visitor parking, and
transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Sara Anderson, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.1643, Silver Spring, MD 20993-0002,
[email protected], 301-796-7047, 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
[[Page 8327]]
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 February 20, 2015, the committee will discuss, make
recommendations, and vote on information regarding the premarket
approval application (PMA) for the Superion InterSpinous Spacer device
sponsored by Vertiflex Inc. The proposed indication for use for the
Superion InterSpinous Spacer device, as stated in the PMA, is as
follows: The Superion InterSpinous Spacer (the Superion ISS) is
intended to treat skeletally mature patients suffering from pain,
numbness, and/or cramping in the legs (neurogenic intermittent
claudication) secondary to a diagnosis of moderate lumbar spinal
stenosis, with or without grade 1 spondylolisthesis, confirmed by x
ray, magnetic resonance imaging, and/or computed tomography evidence of
thickened ligamentum flavum, narrowed lateral recess, and/or central
canal or foraminal narrowing. The Superion ISS is indicated for those
patients with impaired physical function who experience relief in
flexion from symptoms of leg/buttock/groin pain, numbness, and/or
cramping, with or without back pain. The Superion ISS may be implanted
at one or two adjacent lumbar (L) levels in patients in whom treatment
is indicated at no more than two levels, from L1 to L5.
The meeting was originally scheduled for December 12, 2014. The
meeting date is being postponed from December 12, 2014, until February
20, 2015, due to FDA needing additional time to review information
supplied by sponsor.
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
February 18, 2015. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 February 13, 2015. 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 February 17, 2015.
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 Anne Marie 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the February 20, 2015, Orthopaedic and Rehabilitation Panel of the
Medical Devices Advisory Committee meeting. Because the Agency believes
there is some urgency to bring these issues to public discussion and
qualified members of the Orthopaedic and Rehabilitation Panel of the
Medical Devices Advisory Committee were available at this time, the
Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03155 Filed 2-13-15; 8:45 am]
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