Food and Drug Administration
Circulatory System Devices Panel
March 4, 2002
P910014/S016, HeartMate VE LVAS
Briefing Information
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.
Sponsor Presentation - Thoratec Corporation pdf
Draft Summary of Safety and Effectiveness pdf
Patient Handbook pdf
Instructions for Use pdf