NEUROLOGICAL DEVICES PANEL

SEPTEMBER 16, 1999

Letter to Panel Members, dated August 12, 1999

TAB 1

Agenda

Roster

Classification Information

TAB 2

Letter to Panel Member, undated

Questions

Guidance Document for Dura Substitute Devices

TAB 3

Letter to Panel Members, dated August 10, 1998

Questions

Summary Minutes of the February 2, 1990 Neurological Devices Panel

Lang, C.J.G, J.G. Heckmann, B. Neundorfer, "Creutzfeldt-Jakob disease via dural and corneal transplants," Journal of the Neurological Sciences, 160 (1998) 128-139. *

Guidance for the Preparation of a Premarket Notification Application for Processed Human Dura Mater

 

*Copyrighted material. Material maybe view at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852