Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Committee Meeting on January 25, 2011 from 8 a.m. to 6 p.m.

Agenda: On January 25, 2011, the committee will discuss and make recommendations regarding regulatory classification of Automated External Defibrillators to either reconfirm to class III (subject to premarket approval application (PMA)) or reclassify to class II (subject to premarket notification (510(k))), as directed by section 515(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e(i)).