[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56200-56201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23130]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 October 13, 2011, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), and follow the
prompts to the desired center or product area. 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 October 13, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application (PMA) for the Cook, Inc., ZILVER-PTX Drug-Eluting
Stent. The ZILVER-PTX Stent is a self-expanding nitinol stent coated on
its outer surface with the cytotoxic drug paclitaxel without any
polymer, binder, or excipient at a dose density of 3 micrograms/square
millimeter. The ZILVER-PTX Stent is available in diameters ranging from
5 to 10 millimeters (mm) and lengths of 20 to 80 mm and are pre-loaded
onto 6 or 7 Fr \1\ (diameter of 2 or 2.3 mm) delivery systems. Upon
deployment, the ZILVER-PTX Stent expands to establish and maintain
patency in the stented region. The proposed indications for use are:
treatment of de novo or restenotic symptomatic vascular disease of the
above-the-knee femoropopliteal arteries having reference vessel
diameter from 4 mm to 9 mm and total lesion lengths per patient of 280
mm.
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\1\ ``Fr'' stands for French. It is a term that defines the
diameter of a catheter.
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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/AdvisoryCommittees/Calendar/default.htm. 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
October 5, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on October 13, 2011. Those
individuals interested in making 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
September 28, 2011. 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 September 30,
2011.
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 at
301-796-5966 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on
[[Page 56201]]
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: September 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-23130 Filed 9-9-11; 8:45 am]
BILLING CODE 4160-01-P