[Federal Register: July 27, 2007 (Volume 72, Number 144)]
[Notices]
[Page 41334-41335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jy07-54]
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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 September 19, 2007, from
8 a.m. to 6 p.m., and September 20, 2007, from 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512625. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On September 19, 2007, the committee will discuss, make
[[Page 41335]]
recommendations and vote on a premarket approval application, sponsored
by SyntheMed, Inc., for the REPEL-CV, which is a surgical adjuvant
indicated for reducing the incidence, severity and extent of post-
operative adhesion formation in patients undergoing cardiac surgery.
On September 20, 2007, the committee will discuss and make
recommendations regarding clinical trial designs for cardiac ablation
devices designed to treat patients with medically refractory atrial
fibrillation.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
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 on or before
September 5, 2007. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of committee
deliberations on each day and for approximately 30 minutes near the end
of the deliberations on each day. Those desiring to make formal oral
presentations should notify the contact person 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
on or before August 28, 2007. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August
29, 2007.
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 240-276-8932, 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: July 23, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14600 Filed 7-26-07; 8:45 am]
BILLING CODE 4160-01-S