[Federal Register Volume 77, Number 82 (Friday, April 27, 2012)]
[Notices]
[Pages 25183-25184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


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 June 13, 2012, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, 
C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel 
telephone number is 301-977-8900.
    Contact Person: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 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

[[Page 25184]]

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 June 13, 2012, the committee will discuss, make 
recommendations and vote on information related to the premarket 
approval application for the Edwards SAPIEN Transcatheter Heart 
Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN 
Transcatheter Heart Valve is indicated for use in patients with 
symptomatic severe aortic stenosis who have high operative risk.
    The Edwards SAPIEN Transcatheter Heart Valve, model 9000TFX, 
sizes 23mm and 26mm and accessories implant system consists of the 
following:
    <bullet> A heterologous (bovine) pericardium leaflet valve 
sutured within a stainless steel mesh frame, with a polyester skirt. 
It is offered in two sizes, a 23 mm and a 26 mm.
    <bullet> The RetroFlex 3 Delivery System is used to advance the 
bioprosthesis through the RetroFlex sheath over a guidewire and to 
track the bioprosthesis over the aortic arch and for crossing and 
positioning in the native valve. The delivery system also comes with 
a sheath, introducer, loader, dilator, balloon (used to pre-dilate 
the native annulus) and a crimper.
    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 meeting 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 
June 5, 2012. On June 13, 2012, oral presentations from the public 
will be scheduled between approximately 1 p.m. and 2 p.m. 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 May 29, 2012. 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 
June 1, 2012.
    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 James Clark, 
Conference Management Staff, at <a href="/cdn-cgi/l/email-protection#0a406b676f792449666b78614a6c6e6b24626279246d657c"><span class="__cf_email__" data-cfemail="480229252d3b660b24293a23082e2c296620203b662f273e">[email protected]</span></a> or 301-796-
5293 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 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: April 19, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-10156 Filed 4-26-12; 8:45 am]
BILLING CODE 4160-01-P


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