July 15,2005

Grassley, Baucus Comment on FDA Approval of Cyberonics VNS Therapy

M E M O R A N D U M

TO: Reporters and Editors
FR: Jill Kozeny, for Sen. Grassley, 202/224-1308
Wendy Carey, for Sen. Baucus, 202/224-6769
RE: FDA, Cyberonics
DA: Friday, July 15, 2005

Senate Finance Committee Chairman Chuck Grassley and Ranking Member MaxBaucus issued the following comment this afternoon.

"The Finance Committee will continue its inquiry into the Food and DrugAdministration's consideration of the pre-market approval supplement for the vagusnerve stimulator to be used for depression that is treatment-resistant. Both theeffectiveness and the safety of medical devices must be ensured prior to their approval bythe Food and Drug Administration."