[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Page 27581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12792]


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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 June 23, 1999, 8 a.m. to 
6 p.m., and June 24, 1999, 8 a.m. to 5 p.m.
    Location: Hilton Hotel, Salons C, D, and E, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: John E. Stuhlmuller, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8243, ext. 157, 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 June 23, 1999, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
an endovascular graft for the treatment of abdominal aortic aneurysms. 
Subsequently, the committee will discuss, make recommendations, and 
vote on a PMA for an endovascular graft for the treatment of abdominal 
aortic or aorto-iliac aneurysms. On June 24, 1999, the committee will 
discuss, make recommendations, and vote on a PMA for a prosthetic heart 
valve. Subsequently, the committee will discuss, make recommendations, 
and vote on a PMA for a dual-chamber defibrillator for the treatment of 
atrial and ventricular tachyarrhythmias.
    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 June 13, 1999. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on June 23, 1999 and June 24, 1999. 
Near the end of committee deliberations on both days, a 30-minute open 
public hearing will be conducted for interested persons to address 
issues specific to the topics before the committee. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before June 13, 1999, 
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: May 14, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-12792 Filed 5-19-99; 8:45 am]
BILLING CODE 4160-01-F