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Regulatory Science/The Science Board/Standard Development

The 2nd Medical Devices Subcommittee Meeting

Press Release

Date and Time: November 28, 2012  from 6pm to 8pm

Agenda / List of Handouts

Agenda
  1. Proceedings of the Medical Devices Subcommittee
  2. Review process of Medical Devices
  3. Others
List of Handouts
  • Document 1 Reorganization of Offices of Biologics and their new work assignment
  • Document 2 Targeted outcomes of the Subcommittees
  • Document 3 Flow of how to suggest and adopt agendas of the Subcommittees
  • Document 4-1 Review report on "DuraHeart Left Ventricular Assist System"
  • Document 4-2 Report of review on "DuraHeart Left Ventricular Assist System"
  • Document 5 Review Report of "DuraHeart Left Ventricular Assist System"
  • Document distributed at the meeting Issues during the review and current challenges of "DuraHeart Left Ventricular Assist System"
  • Document 6-1 Report of review on "TAXUS Express2 Stent"
  • Document 6-2 Report of review on "TAXUS Express2 Stent" 
  • Document 7 Review Report of "TAXUS Express2 Stent"
  • Document distributed at the meeting Issues at the review and current challenges of "TAXUS Express2 Stent"
  • Document 8 Proposed agenda of the Medical Devices Subcommittee
  • Ref.1 Overview of review process of medical devices