[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Notices]               
[Page 53982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se03-83]                         

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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 October 2, 2003, from 9 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons C, D, and 
E, 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: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an excimer laser and laser 
catheters used for treatment of chronic critical limb ischemia 
(associated with Rutherford Categories 4, 5, and 6). The device is 
intended for use in patients with angiographically evident culprit 
stenoses and/or occlusions in the superficial femoral artery, popliteal 
and/or infrapopliteal arteries, who are poor surgical candidates and 
who are acceptable candidates for revascularization. Background 
information for the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. 
Material will be posted on October 1, 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 September 22, 
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 
September 22, 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, 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: September 8, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23331 Filed 9-12-03; 8:45 am]

BILLING CODE 4160-01-S