[Federal Register: February 19, 2009 (Volume 74, Number 32)]
[Notices]
[Page 7696-7697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19fe09-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 March 18, 2009, from 8
a.m. to 5:30 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, 240-276-4050, 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
[[Page 7697]]
about possible modifications before coming to the meeting.
Agenda: The committee will discuss, make recommendations, and vote
on a premarket approval application, sponsored by TherOx, Inc., for the
TherOx Aqueous Oxygen System (AO System). The system is intended for
use in acute myocardial infarction (AMI) patients, who have undergone
successful revascularization less than or equal to 6 hours from symptom
onset. These patients were randomized to AO Therapy or not. The
endpoint is reduction in the final size of the infarct. The system
draws blood from the patient, hyperoxygenates it with the AO cartridge
component of the system, and reinfuses the blood via the infusion
catheter directly to the infarction site of the heart. This therapy is
intended to be performed for 90 minutes post percutaneous coronary
intervention/stenting.
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 2009 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
March 4, 2009. Oral presentations from the public will be scheduled
approximately 30 minutes at the beginning of committee deliberations
and approximately 30 minutes near the end of the deliberations. 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 February 25, 2009.
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 February 26, 2009.
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.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-3488 Filed 2-18-09; 8:45 am]
BILLING CODE 4160-01-S