Food and Drug Administration

Circulatory System Devices Panel

March 4, 2002

P910014/S016, HeartMate VE LVAS

Briefing Information


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.

Sponsor Presentation - Thoratec Corporation   pdf

Draft Summary of Safety and Effectiveness   pdf

Patient Handbook   pdf

Instructions for Use   pdf

FDA Presentation   ppt   htm