
[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56200-56201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23130]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \1\ ``Fr'' stands for French. It is a term that defines the 
diameter of a catheter.
---------------------------------------------------------------------------

    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


