[Federal Register Volume 63, Number 59 (Friday, March 27, 1998)]
[Notices]
[Page 14945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7981]


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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 regulatory issues.
    Date and Time: The meeting will be held on April 23, 1998, 8 a.m. 
to 6 p.m., and April 24, 1998, 9 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
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 April 23, 1998, the committee will: (1) Discuss and make 
recommendations on a premarket notification submission for a vascular 
graft used in hemodialysis access; and (2) provide input for 
preclinical and clinical data requirements necessary to evaluate 
devices used as adjuncts to the Heimlich maneuver for treatment of 
foreign-body airway obstruction. On April 24, 1998, the committee will 
discuss, make recommendations, and vote on a premarket approval 
application for a transmyocardial revascularization device.
    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 April 13, 
1998. Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on April 23, 1998. Near the end of 
the committee deliberations, on each specific device being discussed, a 
30-minute open public session will be conducted for interested persons 
to address issues specific to the submission before the committee. Oral 
presentations from the public will be scheduled between approximately 9 
a.m. and 9:30 a.m. on April 24, 1998. Near the end of the committee 
deliberations, on each specific device being discussed, a 30-minute 
open public session will be conducted for interested persons to address 
issues specific to the submission before the committee. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before April 13, 
1998, 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: March 19, 1998.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 98-7981 Filed 3-26-98; 8:45 am]
BILLING CODE 4160-01-F