[Federal Register: February 19, 2003 (Volume 68, Number 33)]
[Notices]               
[Page 8030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe03-83]                         


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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 March 6, 2003, from 
10:30 a.m. to 5:30 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, Salons A, B, 
and C, 9751 Washingtonian Blvd., 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: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a thermal (cold) cardiac 
ablation catheter and generator system intended for cryoablation of 
cardiac tissue to treat patients with atrioventricular tachycardia and 
for mapping of the atrioventricular node. Background information, 
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Material for the March 6, 2003, 
meeting will be posted on March 5, 2003.
    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 February 19, 
2003. Oral presentations from the public will be scheduled for 
approximately 30 minutes at the beginning of committee deliberations 
and for approximately 30 minutes near the end of the deliberations. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
February 19, 2003, 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, 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: February 10, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-3999 Filed 2-18-03; 8:45 am]

BILLING CODE 4160-01-S