[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
