[Federal Register Volume 66, Number 120 (Thursday, June 21, 2001)]
[Notices]
[Page 33257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15590]


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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 July 9, 2001, 10 a.m. to 
6 p.m., and July 10, 2001, 8 a.m. to 6 p.m.
    Location: Marriott Washingtonian Center, Salons A, B, and C, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact: Megan Moynahan, Center for Devices and Radiological Health 
(HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8517, ext. 171, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On July 9, 2001, the committee will hear brief 
presentations on issues related to endovascular grafting systems for 
the treatment of abdominal aortic aneurysms. The committee will then 
discuss, make recommendations, and vote on a premarket approval 
application (PMA) for a percutaneous myocardial revascularization 
system used in the treatment of angina. On July 10, 2001, the committee 
will discuss, make recommendations, and vote on two separate PMAs for 
implantable cardiac devices used in the treatment of congestive heart 
failure.
    Background information for each day's topic, including the agenda 
and questions for the committee, will be available to the public 1 
business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the July 9 meeting will be posted on 
July 6, 2001; material for the July 10 meeting will be posted on July 
9, 2001.
    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 by July 2, 2001. 
On July 9, 2001, oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:30 a.m., and near the end of 
the committee deliberations. On July 10, 2001, oral presentations from 
the public will be scheduled between approximately 8 a.m. and 8:30 
a.m., and between approximately 1:30 p.m. and 2 p.m., and near the end 
of the committee deliberations on each submission. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 2, 2001, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 14, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-15590 Filed 6-20-01; 8:45 am]
BILLING CODE 4160-01-S