[Federal Register: April 23, 2003 (Volume 68, Number 78)]
[Notices]
[Page 20014]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap03-58]
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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 May 29, 2003, from 9
a.m. to 5 p.m.
Location: Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two
Montgomery Village Ave., 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 hear a presentation on postmarket
surveillance of diathermy interactions with implanted leads and
implanted systems with leads. The committee will also discuss, make
recommendations, and vote on a premarket approval application for an
ablation catheter for treatment of atrial fibrillation in patients with
drug refractory paroxysmal atrial fibrillation. 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://www.fda.gov/cdrh/panelmtg.html. Material will be
posted on May 28, 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 May 15, 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 May
15, 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: April 15, 2003.
Lester M. Crawford,
Deputy Commissioner.
[FR Doc. 03-9960 Filed 4-22-03; 8:45 am]
BILLING CODE 4160-01-S