[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Notices]
[Page 36548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15539]


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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 July 20 and 21, 2011, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD 20877.
    Contact Person: James Swink, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1609, Silver Spring, MD 20993-0002, 301-796-6313, 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 July 20, 2011, 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\TM\ Transcatheter 
Heart Valve, model 9000TFX, sizes 23 millimeters (mm) and 26 mm and 
accessories implant system consists of the following:
     The Edwards SAPIEN Transcatheter Heart Valve consists of a 
heterologous (bovine) pericardium leaflet valve sutured within a 
stainless steel mesh frame, with a polyester skirt. It is offered in 2 
sizes, a 23 mm and a 26 mm.
     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.
    On July 21, 2011, the committee will discuss, make recommendations, 
and vote on information related to the humanitarian device exemption 
for the Berlin Heart EXCOR Pediatric Ventricular Assist Device (VAD) 
sponsored by Berlin Heart, Inc. The Berlin Heart EXCOR Pediatric VAD 
device is a pneumatically-driven extracorporeal ventricular assist 
device. It is designed to provide bridge-to-transplant mechanical 
support to the heart. The system consists of one or two extracorporeal 
blood pumps (univentricular or biventricular support), cannulae for the 
connection of the blood pumps to the atria and great arteries, and the 
IKUS Stationary Driving Unit (electro-pneumatic driving system).
    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 July 
14, 2011. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. 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 July 6, 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 July 8, 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, 
Conference Management Staff, 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 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: June 15, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-15539 Filed 6-21-11; 8:45 am]
BILLING CODE 4160-01-P