Document ID: FDA-2013-N-0001-0008
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
Posted Date: 2013-02-15T05:00Z

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11208-11209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03488]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Circulatory System 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: Circulatory System 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 March 20, 2013, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's phone number is 301-948-8900.
    Contact Person: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 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 March 20, 2013, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application for the MitraClip Delivery System sponsored by 
Abbott Vascular. The system consists of three major components: The 
delivery catheter, the steerable sleeve, and the MitraClip device. The 
MitraClip device is a single sized, percutaneously implanted mechanical 
clip for the reduction of mitral regurgitation. The MitraClip device 
grasps and coapts the mitral valve leaflets resulting in fixed 
approximation of the mitral leaflets throughout the cardiac cycle. The 
implantable MitraClip device is fabricated with metal alloys and 
polyester fabric (Clip cover) that are commonly used in cardiovascular 
implants. The proposed indication for use: The MitraClip Delivery 
System is indicated for the percutaneous reduction of significant 
symptomatic mitral regurgitation (MR>=3) in patients who have been 
determined by a cardiac surgeon to be too high risk for open mitral 
valve surgery and in whom existing comorbidities would not

[[Page 11209]]

preclude the expected benefit from correction of the mitral 
regurgitation.
    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 
March 13, 2013. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. on March 20, 2013. 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 1, 2013. 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 4, 2013.
    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 James Clark, 
Conference Management Staff, at James.Clark@fda.hhs.gov or 301-796-
5293, 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: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03488 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P