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44ms
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Sources: EU EUDAMED, US FDA
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Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
FDA Enforcement
Class I
·Terminated·SynCardia Systems Inc.·September 23, 2015
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
FDA Enforcement
Class II
·Terminated·SynCardia Systems Inc.·January 9, 2013
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
FDA Enforcement
Class I
·Terminated·SynCardia Systems Inc.·December 14, 2016