[Federal Register: July 21, 2003 (Volume 68, Number 139)]
[Page 43133-43134]
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 August 20, 2003, from 8 
a.m. to 6 p.m.
    Location: Bethesda Marriott, Congressional Ballroom, 5151 Pooks 
Hill Rd., Bethesda, MD.
    Contact Person: Les Weinstein, Center for Devices and Radiological 
Health (HFZ-5), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-827-7991, FAX 301-827-2565, lsw@cdrh.fda.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 10232. 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 CardioGenesis 
Corp., related to the approvability of a premarket approval application 
for the Axcis Percutaneous Myocardial Revascularization (PMR) for late 
stage medically refractory angina. Background information for the day's 
topic, including the attendee list, agenda, and questions for the 
committee, will be posted on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panel/index.html
 one business day before the meeting.
    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 by August 13, 
2003. Oral presentations from the public will be scheduled between 
approximately 8 a.m. and 8:30 a.m. on August 20, 2003.

[[Page 43134]]

Near the end of the committee deliberations, a 30-minute open public 
session will be conducted for interested persons to address issues 
specific to the dispute before the committee. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 13, 2003, 
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.
    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 AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, 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).

    Dated: July 11, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-18350 Filed 7-18-03; 8:45 am]