[Federal Register: August 20, 2002 (Volume 67, Number 161)]
[Notices]               
[Page 53955]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au02-81]                         

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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 9, 2002, from 
10:30 a.m. to 5 p.m., and September 10, 2002, from 8 a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Geretta Wood, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8320, ext. 143, 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 9, 2002, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
an endovascular graft placed percutaneously to treat infrarenal 
abdominal aortic aneurysms as an alternative to surgery. On September 
10, 2002, the committee will discuss, make recommendations, and vote on 
a supplement to a PMA for a double disk occluder indicated for closure 
of patent foramen ovale in patients at risk for recurrent cryptogenic 
stroke or transient ischemic attack. 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 9, 2002, session will be posted on September 6, 2002; 
material for the September 10, 2002, session will be posted on 
September 9, 2002.
    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 30, 
2002. 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 30, 2002, 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.
    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 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 12, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Affairs.
[FR Doc. 02-21210 Filed 8-19-02; 8:45 am]
BILLING CODE 4160-01-S