Document ID: FDA-2011-N-0002-0110
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee
Posted Date: 2011-09-19T04:00Z

[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58019-58020]
From the Federal Register Online via the Government Printing 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: james.swink@fda.hhs.gov, 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]
BILLING CODE 4160-01-P