summaryminutesofthe.docVIP

SUMMARY MINUTES OF THE GENERAL AND PLASTIC SURGERY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE OPEN SESSION MARCH 1-3, 2000 Grand Ballroom Gaithersburg Holiday Inn Two Montgomery Village Avenue Gaithersburg, Maryland GENERAL AND PLASTIC SURGERY DEVICES PANEL ROSTER March 1-3, 2000 Panel Chair Thomas V. Whalen, MD Robert Wood Johnson Medical School at Camden Voting Members Joseph V. Boykin, MD Columbia Retreat Hospital Phyllis Chang, MD University of Iowa College of Medicine Temporary Voting Members Karen Bandeen-Roche, PhD Johns Hopkins University Brent Blumenstein, PhD American College of Surgeons Oncology Group Boyd Burkhardt, MD Adobe Plastic Surgery Nancy A. Dubler, LLB Albert Einstein College of Medicine Stephen Li, PhD Hospital for Special Surgery Michael J. Morykwas, PhD Bowman Gray School of Medicine John A. Robinson, MD Loyola University Medical Center Consumer Representative Maxine F. Brinkman, RN, MA North Iowa Mercy Health Center Industry Representative Cindy Domecus Conceptus, Inc. FDA Personnel David Krause, PhD Panel Executive Secretary Celia Witten, PhD, MD Director, Division of General and Restorative Devices Jim Dillard, MS Acting Director, Division of General and Restorative Devices Nancy Pluhowski Panel Coordinator Stephen P. Rhodes, MS Branch Chief, Plastic and Reconstructive Surgery Devices Branch Mr. Phil Phillips, MA Deputy Director Office of Device Evaluation OPEN SESSION—March 1, 2000 Panel Executive Secretary Dr. David Krause began the Open Session at 8:10 a.m. and read appointments to temporary voting status for Drs. Bandeen-Roche, Blumenstein, Burkhardt, Dubler, Li, Morykwas, and Robinson. He also read the conflict of interest statement, noting that a waiver had been granted to Dr. Li for his interest in a firm at issue and that matters concerning Drs. Burkhardt, Chang, Li, and Morykwas had been considered but their full participation allowed