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The 2nd Medical Devices Subcommittee Meeting

Press Release

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Monday, November 28, 2012   18:00 - 20:00

Agenda / List of Handouts

  1. Proceedings of the Medical Devices Subcommittee
  2. Review process of Medical Devices
  3. Others

List of Handouts

Seat Assignment
Classification of how to handle the Handouts
1. Reorganization of Offices of Biologics and their new work assignment
2. Targeted outcomes of the Subcommittees
3. Flow of how to suggest and adopt agendas of the Subcommittees
4-1. Review report on "DuraHeart Left Ventricular Assist System" *
4-2. Report of review on "DuraHeart Left Ventricular Assist System"
5. Review Report of "DuraHeart Left Ventricular Assist System"
** Issues during the review and current challenges of "DuraHeart Left Ventricular Assist System"
6-1. Report of review on "TAXUS Express2 Stent" *
6-2. Report of review on "TAXUS Express2 Stent"
7. Review Report of "TAXUS Express2 Stent"
** Issues at the review and current challenges of "TAXUS Express2 Stent"
Ref Overview of review process of medical devices
8. Proposed agenda of the Medical Devices Subcommittee
* Document is classified as "handle with utmost care" and collected after the meeting
** Document is distributed at the meeting

Minutes

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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The 2nd Medical Devices Subcommittee Meeting
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