The Public Agenda Draft

NEUROLOGICAL DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Fifteenth  Meeting

 

Holiday Inn

Walker and Whetstone Ballroom

2 Montgomery Village Avenue

Gaithersburg, Maryland

August 5, 2003

 

Panel Chairperson                                                                                               Executive Secretary

Robert W. Hurst, M.D.                                                                          Janet L. Scudiero, M.S.

 

 10:30      am           Call to Order

Conflict of Interest and Deputization to Voting Member Status Statements

                                Panel Introductions

                                Update Since the November Date, 2000 Meeting

Stephen P. Rhodes, M.S., Chief, General and Plastic Surgery Devices Branch

                                                                 

10:45      am           Open Public Hearing*, up to 30 minutes

 

11:15       am           Microtherapeutics, Inc. Presentation on PMA 030004, The Onyx(r) Liquid Embolic System

                                                Amy Walters, VP Quality Assurance, Clinical & Regulatory                                               

                                                Bill Patterson, Sr. Director, Research & Development

                                                Gary Duckwiler, MD, Principal Investigator

                                                Donald W. Larsen, MD, DSMB

                                                Lee Pride, MD, Clinical Investigator

                                                Tom Wilder, President/CEO

 

12:15       am           Lunch Break

 

 1:00        am           FDA Presentation

                                                Peter L. Hudson, Ph.D., Preclinical Reviewer

                                                Ann Costello, Ph.D., M.D.M., Clinical Reviewer

                                                Judy Chen, M.S., Statistical Reviewer

 

 1:45        pm           Panel Deliberations

                                                Thomas L. Kurt, M.D., M.P.H., Preclinical Review

                                                Mary Lee Jensen, M.D., Clinical Review             

                                                Jonas Ellenburg, Ph.D., Statistical Review

 

 3:15        pm           Break

 

 3:30        pm           Second Open Public Hearing*, up to 30 minutes

                                               

 4:00        pm           FDA and Sponsor Summations, up to 15 minutes each

 

 4:30        pm           Concluding Deliberations and Vote

 

 5:30        pm           Adjournment                        

 

 

* Open Public Hearings - Interested persons may present data, information, or views, orally or in writing, on the issue pending before the panel.  Scheduled speakers who have requested time to address the panel will speak at this time.  After they have spoken, Dr. Hurst may ask them to remain if the panel wishes to question them. Then Dr. Hurst will recognize unscheduled speakers as time allows.

 Note:  Only the panel may question speakers during the open public hearing