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CAUTION
The Companion Driver System is an investigational
device, limited by United States law to investigational
use.
10cc & 30cc VAD prototypes, 50cc TAH-t prototype and Companion II Driver prototype. Not for Human Use. These products are in the research and development phase and will not be available for sale in the United States or Europe until after all regulatory requirements have been met.
The CardioWest TAH-t portable driver is CE Mark approved for use in Europe. It is not FDA approved for use in the U.S. |
