[Federal Register: July 1, 2004 (Volume 69, Number 126)]
[Notices]               
[Page 39943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy04-102]                         

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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 28, 2004, from 9 
a.m. to 5 p.m., and on July 29, 2004, from 9 a.m. to 5 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
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 3014512625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On July 28, 2004, the committee will discuss, make 
recommendations, and vote on a premarket approval application 
supplement for a cardiac resynchronization device. On July 29, 2004, 
the committee will hear a presentation on Adverse Event Reports for 
Automatic External Defibrillators from 1996 to 2003.
    The committee will also discuss and make recommendations on a 
premarket notification (510(k)) submission for an over-the-counter 
automated external defibrillator. Background information for the 
topics, 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 

July 28 session will be posted on July 27, 2004; material for the July 
29 session will be posted on July 28, 2004.
    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 14, 2004. 
On both days, 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 
July 14, 2004, 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: June 24, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-14947 Filed 6-30-04; 8:45 am]

BILLING CODE 4160-01-S