Food and Drug Administration
June 23, 2005
Briefing Information
Abiomed, Inc. H040006: Abiocor Implantable Replacement Heart
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.
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)