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Food and Drug Administration

Medical Devices Dispute Resolution Panel

December 15, 2006

PMA P040049, CorCap Cardiac Support Device (CSD)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Briefing Information (pdf)

Sponsor: Acorn Cardiovascular, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Table of Contents (pdf)

Executive Summary (pdf)

Expert Consultant Opinion Memorandum (pdf)

Attachment to Expert Opinion Memorandum - Expert Consultant (CV's) (pdf)

Attachment to Expert Opinion Memorandum - Expert Report (Multiple Imputation Donald B. Rubin Ph.D.) (pdf)

CorCap CSD Clinical Trial Steering Committee Letter to Medical Devices Dispute Resolution Panel (pdf)

Clinical Study Summary (pdf)

Acorn Corrections to May 23, 2005 FDA Review Memorandum (pdf)

Acorn Corrections to February 1, 2006 FDA Review Memorandum (pdf)

Appendix A - Consolidated Safety Report (pdf)

Appendix B - Study Protocol, Revision 8 (pdf)

Appendix C - Statistical Methods (pdf)

Appendix D - Regulatory Timeline (pdf)

Appendix E - Instructions for Use (pdf)

Appendix F - Bibliography and Publications Cited (pdf)

Appendix G Acorn Explanations of Unresolved Issues (pdf)

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