Food and Drug Administration

Circulatory System Devices Panel

June 22, 2005

Briefing Information

Acorn Cardiovascular P040049: CorCap CSD

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.

CorCap® Cardiac Support Device Patient Information Booklet (HTM) (PDF) (Word)

FDA Summary Memorandum, Michael Berman, PhD (HTM) (PDF) (Word)

Summary of Safety and Effectiveness (HTM) (PDF) (Word)

CorCap™ Cardiac Support Device Instructions for Use (HTM) (PDF) (Word)

CorCap CSD PMA Brief Clinical Summary (HTM) (PDF) (Word)

FDA Clinical Review, Ileana Pina, MD and Julie Swain, MD (HTM) (PPT)

FDA Presentation, Michael Berman, PhD, et. al. (HTM) (PPT)

CorCap CSD Condition of Approval Study, Brock Hefflin, MD, FDA (HTM) (PPT)

Statistical Review, Laura Thompson, PhD, FDA (HTM) (PPT)