Document ID: FDA-2015-N-0001-0105
Agency: fda
Document Type: Notice
Title: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
Posted Date: 2015-11-23T05:00Z

[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72971-72972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29768]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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.

[[Page 72972]]

    Date and Time: The meeting will be held on Friday, February 19, 
2016, from 8 a.m. to 6 p.m.
    Location: Hilton Washington, DC/North, Salons A, B, C, and D, 620 
Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301-
977- 8900.
    Contact Person: Sara Anderson, Center for Devices and Radiological 
Health, Food and Drug Administration, Bldg. 66, Rm.1643, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 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: The Committee will discuss the premarket application for 
the DIAM Spinal Stabilization System. The DIAM Spinal Stabilization 
System is indicated for skeletally mature patients that have low back 
pain (with or without radicular pain) with current episode lasting less 
than 1 year in duration secondary to moderate lumbar degenerative disc 
disease (DDD) at a single level from L2-L5. DDD is confirmed 
radiographically with one or more of the following factors: (1) 
Patients must have greater than 2 millimeters of decreased disc height 
compared to the adjacent level; (2) scarring/thickening of the 
ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) 
herniated nucleus pulposus. The DIAM device is implanted via a 
minimally invasive posterior approach.
    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 12, 2016. 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 4, 2016. 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 5, 2016.
    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 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at 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: November 13, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-29768 Filed 11-20-15; 8:45 am]
 BILLING CODE 4164-01-P