[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36248-36249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17596]


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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 21 and 22, 1998, 8 
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 July 21, 1998, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
a cardiac ablation device for ventricular tachycardia. On July 22, 
1998, the committee is being asked to provide input to the agency 
regarding the design of clinical trials to support PMA's for cardiac 
ablation devices intended to treat atrial fibrillation and atrial 
flutter. Of particular concern are the following issues: (1) What are 
the appropriate controls to be used in such trials? (2) What are the 
appropriate safety and efficacy measures? and (3) When should 
assessments of these measures be made?
    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 10, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. Near the end of

[[Page 36249]]

committee deliberations on both days, a 30-minute open public hearing 
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 July 10, 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: June 26, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17596 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F