of the


Eighteenth Meeting

Hilton Washington D.C. North

620 Perry Parkway

Gaithersburg, Maryland

November 30, 2004

Panel Chairperson Executive Secretary

Kyra J. Becker, M.D. Janet L. Scudiero, M.S.


Confluent Surgical, Inc., DuraSeal Dura Sealant System, P040034


8:45 am Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

Panel Introductions

Update since the June 15, 2004 Meeting

Stephen Rhodes, Chief, Plastic and Reconstructive Surgery Devices Branch (PRSB)

9:00 am 1st Open Public Hearing*

9:30 am Sponsor Presentation

Eric P. Ankerud, J.D., Vice President, Clinical, Regulatory and Quality,

Confluent Surgical, Waltham, MA

Patrick Campbell, Ph.D. Vice President, Research and Development

Confluent Surgical, Waltham, MA

John M. Tew, Jr., M.D., Mayfield Clinic and Professor, Department of Neurosurgery,

University of Cincinnati

G. Rees Cosgrove, M.D., F.R.C.S. (C.), Associate Professor, Neurosurgery,

Harvard Medical School, Massachusetts General Hospital, Boston, MA

Harry van Loveren, M.D., Tampa General Hospital and Professor and Chairman, Director

of Skull Base and Cerebrovascular Surgery, University of South Florida

10:30 am Break


10:45 am FDA Presentation

Peter L. Hudson, Ph.D.

Michael J. Schlosser, M.D.

11:30 pm Lunch

12:30 pm Panel Deliberations and FDA Questions

Alexa I. Canady, M.D.

David T. MacLaughlin, Ph.D.


2:30 pm 2nd Open Public Hearing*


3:00 pm Break


3:15 pm FDA and Sponsor Summations, up to 15 minutes each

3:45 pm Panel Vote


5:00 pm Adjournment


* Open Public Hearings Interested persons may present data, information, or views, orally or in writing, on the meeting agenda. Scheduled speakers who have requested time to address the panel will speak at this time. After they have spoken, the Chair will recognize unscheduled speakers as time allows. Only the panel may question speakers during the open public hearing.