[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56589-56590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


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 December 12, 2014, from 
8 a.m. to 6 p.m.
    Location: Holiday Inn Washington-College Park, 10000 Baltimore 
Ave., College Park, MD 20740. The hotel phone number is 1-800-315-2621.
    Contact Person: S.J. Anderson, Center for Devices and Radiological 
Health, 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 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 December 12, 2014, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application for the Superion InterSpinous Spacer device 
sponsored by Vertiflex Incorporated. 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, MRI and/or CT 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.
    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 
November 13, 2014. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on December 12, 2014. 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 
November 5, 2014. 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 November 6, 
2014.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.

[[Page 56590]]

    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 301-796-5966. [email protected] 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: September 16, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-22444 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P