Document ID: FDA-2010-N-0001-0013
Agency: fda
Document Type: Notice
Title: Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7282-7283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-44]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-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 March 18 and 19, 2010, 
from 8 a.m. to 6 p.m.
    Location: College Park Holiday Inn, Grand Ballroom, 10000 Baltimore 
Ave., College Park, MD.
    Contact Person: James Swink, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD

[[Page 7283]]

20993, 301-796-6313, e-mail: James.Swink@fda.hhs.gov, 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 March 18, 2010, the committee will discuss, make 
recommendations, and vote on the premarket approval application (PMA) 
for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) 
sponsored by Boston Scientific. The sponsor is seeking expanded 
indications for the their CRT-Ds to include patients with low left 
ventricular ejection fraction (<=30%) and wide QRS (>=130 ms) who are 
NYHA Class II (ischemic or non-ischemic etiology) or NYHA Class I 
(ischemic etiology).
    On March 19, 2010, the committee will discuss, make recommendations 
and vote on a PMA for the REVO MRI Pacemaker System sponsored by 
Medtronic. The REVO MRI Pacing System is a pacemaker (with a standard 
pacing indication) that has been specifically designed to be safe for 
the MRI environment under certain MR scanning conditions.
    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 
March 11, 2010. Oral presentations from the public will be scheduled 
immediately following lunch. 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 March 3, 2010. 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 March 4, 
2010.
    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 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: February 4, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-3032 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S