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  4. September 27, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 09/27/2018 - 09/27/2018
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Advisory Committee Meeting

Event Title
September 27, 2018: Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
September 27, 2018


Date:
September 27, 2018
Time:
08:00 AM - 05:00 PM EDT

Center Date Time Location
CDRH September 27, 2018 8:00 a.m. - 5:00 p.m. Hilton Washington, DC/North
620 Perry Pkwy.
Salons A, B, C, and D Gaithersburg, MD 20877
301–977–8900

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2946]

Neurological Devices Panel Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA or Agency) announces a forthcoming public Advisory Committee meeting of the Neurological Devices Panel (Committee).  The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.  The meeting will be open to the public.

DATES:  The meeting will be held on September 27, 2018, from 8 a.m. to 5 p.m.

ADDRESSES:  Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD  20877.  The hotel’s phone number is 301-977-8900 and website is: http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:  https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT:  Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD  20993-0002, Aden.Asefa@fda.hhs.gov, 301-796-0400, 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 website at https://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.

SUPPLEMENTARY INFORMATION:

Agenda:  On September 27, 2018, the Committee will discuss, make recommendations, and vote on the premarket approval application sponsored by Sequent Medical, Inc. for the Woven Endobridge (WEB) Aneurysm Embolization System, which is intended to treat wide-neck intracranial aneurysms arising or located at a vessel bifurcation.  The WEB device is being evaluated in the WEB Intrasaccular Therapy Study (WEB-IT):  a multicenter, prospective, non-randomized investigation.  The Committee will be asked to review the clinical data from the WEB-IT study to help the Agency assess the safety and effectiveness of the device for the proposed indications for use.

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 website 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 website after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/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 September 20, 2018.  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 September 12, 2018.  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 September 13, 2018.

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 Artair Mallett at Artair.Mallett@fda.hhs.gov  or 301-796-9638 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our website at https://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:  August 14, 2018.

Leslie Kux,

Associate Commissioner for Policy.
 


Meeting Materials

Title File Type/Size Source Organization
Neurological Devices Panel Sept. 27, 2018 2018 Acknowledgment of Financial Interests: Nicole R. Gonzales, M.D. (45.61 KB) Neurological Devices Panel Sept. 27, 2018 2018 Acknowledgment of Financial Interests: Nicole R. Gonzales, M.D.
Neurological Devices Panel Sept. 27, 2018 2018 Waiver: Nicole R. Gonzales, M.D. (60.71 KB) Neurological Devices Panel Sept. 27, 2018 2018 Waiver: Nicole R. Gonzales, M.D.
Neurological Devices Panel Sept. 27, 2018 Agenda (44.29 KB) Neurological Devices Panel Sept. 27, 2018 Agenda
Neurological Devices Panel Sept. 27, 2018 Roster (33.74 KB) Neurological Devices Panel Sept. 27, 2018 Roster
Neurological Devices Panel Sept. 27, 2018 Voting Questions (30.26 KB) Neurological Devices Panel Sept. 27, 2018 Voting Questions
Neurological Devices Panel Sept. 27, 2018 FDA Executive Summary Neurological Devices Panel Sept. 27, 2018 FDA Executive Summary
Neurological Devices Panel Sept. 27, 2018 Presentation (Panel Questions) (281.03 KB) Neurological Devices Panel Sept. 27, 2018 Presentation (Panel Questions)
Neurological Devices Panel Sept. 27, 2018 Presentation (FDA) (607.43 KB) Neurological Devices Panel Sept. 27, 2018 Presentation (FDA)
Neurological Devices Panel Sept. 27, 2018 24 Hour Summary (50.79 KB) Neurological Devices Panel Sept. 27, 2018 24 Hour Summary
Neurological Devices Panel Sept. 27, 2018 Transcript Neurological Devices Panel Sept. 27, 2018 Transcript
Neurological Devices Panel Sept. 27, 2018 Sponsor Executive Summary Neurological Devices Panel Sept. 27, 2018 Sponsor Executive Summary
Neurological Devices Panel Sept. 27, 2018 Presentation (Sponsor) Neurological Devices Panel Sept. 27, 2018 Presentation (Sponsor)

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)

Please call the Information Line for up-to-date information on this meeting.

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 and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

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 Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).