[Federal Register: November 6, 2007 (Volume 72, Number 214)]
[Notices]               
[Page 62658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no07-71]                         


[[Page 62658]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 November 29 and 30, 
2007, from 8 a.m. to 6 p.m.
    Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village 
Ave., Gaithersburg, MD.
    Contact Person: James Swink, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512625. 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 appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On November 29, 2007, the committee will discuss, make 
recommendations, and vote on a premarket approval application, 
sponsored by Abbott Vascular, for the XIENCE V Everolimus Eluting 
Coronary Stent System, which is indicated for improving coronary 
luminal diameter in patients with symptomatic heart disease due to de 
novo native coronary artery lesions (length = 28 millimeters (mm)) with 
reference vessel diameter of 2.5 mm to 4 mm.
    On November 30, 2007, the committee will discuss, make 
recommendations, and vote on a premarket approval application, 
sponsored by Thoratec Corp., for the HeartMate II Left Ventricular 
Assist System (LVAS), which is intended for use as a bridge to 
transplantation in cardiac transplant candidates at risk of imminent 
death from non-reversible left ventricular failure. The HeartMate II 
LVAS is intended for use both inside and outside the hospital.
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
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 15, 2007. Oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of committee 
deliberations on each day and for approximately 30 minutes near the end 
of the deliberations on each day. Those desiring to make 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 7, 2007. 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 
8, 2007.
    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, 
Conference Management Staff, at 240-276-8932, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.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: October 31, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-21779 Filed 11-5-07; 8:45 am]

BILLING CODE 4160-01-S