[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Page 13288-13289]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Medical Devices Dispute Resolution Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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: Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on scientific disputes between the Center 
for Devices and Radiological Health and sponsors, applicants, and 
    Date and Time: The meeting will be held on April 19, 2007, from 
8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Nancy Collazo-Braier, Center for Devices and 
Radiological Health (HFZ-1), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3959, e-mail: 
nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 

1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014510232. Please call the Information Line for up-to-date information 
on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
regarding a scientific dispute between the agency and Cardima Inc. 
related to the not-approvable determination for the premarket approval 
application (PMA) for the REVELATION Tx Microcatheter with NavAblator 
Ablation System, indicated for the treatment of drug refractory 
paroxysmal atrial fibrillation.
    FDA intends to make background material available to the public no 
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 
April 5, 2007. Oral presentations from the public will be scheduled 
between approximately 9 a.m. and 9:30 a.m. and between approximately 
1:30 p.m. and 2 p.m. 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 28, 2007. 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 29, 2007.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Ann Marie Williams, 
Conference Management Staff, at 301-827-7291, at least 7 days in 
advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

[[Page 13289]]

    Dated: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5152 Filed 3-20-07; 8:45 am]