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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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