Document ID: FDA-2015-N-0001-0019
Agency: fda
Document Type: Notice
Title: Neurological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
Posted Date: 2015-02-24T05:00Z

[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9733-9734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03687]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Neurological 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: Neurological 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 April 17, 2015, from 8 
a.m. to 4 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. 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: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, Jamie.Waterhouse@fda.hhs.gov, 301-796-
3063, 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 April 17, 2015, the committee will discuss the current 
knowledge regarding the conduct of clinical studies and evaluation of 
clinical study data for flow diverter technology. FDA is convening this 
committee to seek expert opinion on scientific and clinical 
considerations relating to the study design and existing clinical 
studies, for flow diverter technology indicated for the 
neurovasculature.
    Flow diverters are an endoluminal treatment option for intracranial 
aneurysms. They are similar to traditional stents in their tubular 
metal structure but with a significantly higher mesh density. The 
working principle is that the high-mesh density reduces flow rate into 
the aneurysm which promotes blood stasis and occlusion of the aneurysm. 
Flow diverters are advantageous for the treatment of large/giant wide-
neck aneurysms and offer an alternative to other interventional 
techniques or surgery.
    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 
April 3, 2015. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11:30 a.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 March 24, 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 March 27, 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 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 http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on

[[Page 9734]]

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: February 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03687 Filed 2-23-15; 8:45 am]
BILLING CODE 4164-01-P