BEUDAMED
    2 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class I × Status: Terminated × Clear all

    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

    FDA Enforcement
    Class I ·Terminated·Thoratec Corporation·April 2, 2014

    HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD. HeartMate II attaches to the heart and is designed to assist or take over the pumping function of the patients left ventricle, the main pumping chamber of the heart.

    FDA Enforcement
    Class I ·Terminated·Thoratec Corporation·April 2, 2014