[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]
BILLING CODE 4164-01-P