Document ID: FDA-2009-N-0664-0013
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee - Notice of Meeting
Posted Date: 2009-02-19T05:00Z

[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://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://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