Circulatory System Devices Panel of
the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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
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 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/Advisory
Committees/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
[FR Doc. 2010–3032 Filed 2–17–10; 8:45 am]
BILLING CODE 4160–01–S