[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
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 https://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 https://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
