[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58019-58020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23875]
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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 October 26 and 27, 2011,
from 8 a.m. to 6 p.m.
Location: Hilton Washington, DC, North/Gaithersburg, salons A, B,
C, and D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993, e-mail: [email protected], 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
[[Page 58020]]
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 October 26, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application sponsored by AtriCure, Inc., for the AtriCure
Synergy Ablation System to be used for the treatment of atrial
fibrillation in patients who are undergoing open concomitant cardiac
surgery. The AtriCure Synergy Ablation System consists of the
following:
The AtriCure Isolator Synergy Handpieces (models OLL2 and
OSL2), which resemble surgical clamps, include a syringe-type grip
handle/actuator, connected by a cylindrical shaft to a pair of grasping
jaws with electrodes on each jaw. The electrodes deliver radiofrequency
(RF) energy to the tissue grasped by the jaws.
The Ablation and Sensing Unit is an RF generator used to
power the Isolator Synergy Handpieces.
The Isolator Switch Matrix is an accessory interface
module allowing the Isolator Synergy Handpieces to connect to the RF
generator.
On October 27, 2011, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the Medtronic Ablation Frontiers Cardiac
Ablation System sponsored by Medtronic, Inc. The Medtronic Ablation
Frontiers Cardiac Ablation System is a catheter-based device developed
for the treatment of atrial fibrillation. The system consists of the
following:
The Pulmonary Vein Ablation Catheter, which is designed to
create lesions in the left atrium via five pairs of electrodes to
isolate the pulmonary veins. It has a deflectable distal end and
bidirectional steering to aid in positioning the catheter
appropriately.
The Multi-Array Septal Catheter, which is designed to
create lesions on the septal wall of the left atrium via six pairs of
electrodes. It is not steerable and is intended to be used in a
transseptal approach.
The Multi-Array Ablation Catheter, which is designed to
create ``X''-like lesions in the left and/or right atrium via four
pairs of electrodes. It has a deflectable distal segment and
bidirectional steering within a single plane.
The GENius Multi-Channel RF Ablation Generator.
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
October 19, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on October 26 and 27. 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
October 11, 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 October 13,
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, 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: September 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-23875 Filed 9-16-11; 8:45 am]
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