Food and Drug Administration

Circulatory System Devices Panel

June 23, 2005

Briefing Information

Abiomed, Inc. H040006: Abiocor Implantable Replacement Heart


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.

Abiomed Instructions for Use (HTM) (PDF) (Word)

Clinical Summary (HTM) (PDF) (Word)

Summary of Safety and Probable Benefit (HTM) (PDF) (Word)

FDA Summary (HTM) (PDF) (Word)

FDA Clinical Abiomed Presentation, Eric Chen, MS (HTM) (PPT)

FDA Clinical Abiocor Presentation, Julie Swain, MD (HTM) (PPT)

Abiocor Questions for the Panel (HTM) (PPT)