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Dockets Management

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Food and Drug Administration

Medical Devices Dispute Resolution Panel

December 15, 20006

Draft Slides

FDA

Acorn CorCap Cardiac Support Device, FDA Review of P040049 - Speaker 1. Bram Zuckerman, M.D. – Intro to Device, Indications, File History & Intro to FDA Review of Acorn CorCap PMA. Speaker 2. William Maisel, M.D., M.P.H. – Summary of June 22, 2005 Advisory Panel Meeting. Speaker 3. Ileana Pina, M.D. – Clinical Review of Acorn CorCap PMA. Speaker 4. Laura Thompson, Ph.D. – Statistical Review of Acorn CorCap PMA. Speaker 5. Clyde Yancy, M.D. – Advisory Panel Member's Perspective. Speaker 6. Aron Yustein, M.D. – Conclusion and Recommendation (pdf)

Sponsor: Acorn

Acorn Cardiovascular, Inc. CorCap Cardiac Support Device (P040049) (pdf)

Expert Comment on Scientific Issues in Dispute (pdf)

Summary of the CorCap CSD Clinical Study – Mariell Jessup, M.D. (pdf)

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