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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant: THORATEC CORP Product Code: DSQ Decision Date to 11/19/2017
 
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PMA
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thoratec heartmate ii and heartmate 3 ventricular assist sys... THORATEC CORP. P060040 S068 10/12/2017
heartmate ii left ventricular assist system THORATEC CORP. P060040 S069 10/12/2017
thoratec heartmate ii and heartmate 3 ventricular assist sys... Thoratec Corporation P160054 S001 10/12/2017
heartmate 3™ left ventricular assist system Thoratec Corporation P160054 S002 10/12/2017
heartmate 3™ left ventricular assist system Thoratec Corporation P160054 08/23/2017
thoratec, heartmate ii, ventricular assist system THORATEC CORP. P060040 S067 08/17/2017
heartmate ii lvas THORATEC CORP. P060040 S065 06/30/2017
thoratec heartmate ii left ventricular assist system THORATEC CORP. P060040 S059 06/23/2017
heartmate ii lvas THORATEC CORP. P060040 S066 04/11/2017
thoratec heartmate ii left ventricular assist system THORATEC CORP. P060040 S064 03/02/2017
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