[Federal Register Volume 66, Number 166 (Monday, August 27, 2001)]
[Notices]
[Page 45053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21528]


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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 September 10, 2001, from 
9 a.m. to 6 p.m., and September 11, 2001, from 8 a.m. to 6 p.m.
    Location: Marriott Hotel, Salons D, E, and F, 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 September 10, 2001, the committee will discuss, make 
recommendations, and vote on two premarket approval applications (PMAs) 
for septal occluders. On September 11, 2001, the committee will 
discuss, make recommendations, and vote on two PMAs, one for a surgical 
sealant and one for a biological glue. 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 
September 10, 2001, meeting will be posted on September 7, 2001; 
material for the September 11, 2001, meeting will be posted on 
September 10, 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 August 31, 
2001. On both days, oral presentations from the public will be 
scheduled for approximately 30 minutes at the beginning of each topic 
and for approximately 30 minutes near the end of the committee 
deliberations. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before August 31, 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: August 20, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21528 Filed 8-24-01; 8:45 am]
BILLING CODE 4160-01-S