Document ID: FDA-2009-N-0664-0058
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2009-07-02T04:00Z

[Federal Register: July 2, 2009 (Volume 74, Number 126)]
[Notices]               
[Page 31743-31744]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jy09-65]                         

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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). At least one 
portion of the meeting will be closed 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 22 and 23, 2009, 
from 8 a.m. to 6 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 about possible modifications before coming to the meeting.
    Agenda: On July 22, 2009, the committee will discuss, make 
recommendations, and vote on a Humanitarian Device Exemption (HDE) 
application, sponsored by Medtronic, Inc., for the MEDTRONIC MELODY 
Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE 
Transcatheter Valve Delivery System (NU10). The MEDTRONIC MELODY 
Transcatheter Pulmonary Valve (Model PB10) and MEDTRONIC ENSEMBLE 
Transcatheter Valve Delivery System (NU10) is indicated for use in 
patients with the following clinical conditions:
    Regurgitant (insufficient or leaky) Right Ventricular Outflow Tract 
(RVOT)--The right ventricular outflow tract is that portion of the 
right ventricle leading up to the pulmonary valve and pulmonary artery. 
When the ventricles contract, blood moves along the outflow tract and 
through the pulmonary valve; blood then flows to the lungs where gas 
exchange takes place.
     Conduits--In the context of this device, a surgically implanted 
tube that allows blood to pass from the heart to the pulmonary 
arteries.
      Stenotic (stiff valve leaflets that cannot open or close 
properly) RVOT conduits where the risk of worsening regurgitation is a 
relative contraindication to balloon dilatation or stenting.
      Existence of a full (circumferential) RVOT conduit that 
was equal to or greater than 16 millimeters (mm) in diameter when 
originally implanted.
    On July 23, 2009, from 8 a.m. to 10 a.m., and from 1 p.m. to 6 
p.m., the committee will discuss general questions about adhesion 
barriers for cardiovascular use. Some of these questions will focus on 
understanding the target population (pediatric and/or adult) that would 
benefit from these devices and the development of appropriate endpoints 
for a clinical trial.
    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, click on the year 2009, scroll down to the appropriate 
advisory committee link.
    Procedure: On July 22, 2009, from 8 a.m. to 6 p.m., and on July 23, 
2009, from 8 a.m. to 10 a.m. and from 1 p.m. to 6 p.m., the meeting is 
open to the public. 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 
15, 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 July 7, 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 July 8, 2009.
    Closed Presentation of Data: On July 23, 2009, from 10 a.m. to 12 
noon, the meeting will be closed to permit discussion and review of 
trade secret and confidential commercial information (5 U.S.C. 
552b(c)(4)) related to the design of a potential clinical trial.
    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

[[Page 31744]]

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 26, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-15680 Filed 7-1-09; 8:45 am]

BILLING CODE 4160-01-S