6 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
FDA Enforcement
Class II
·Ongoing·Thoratec Corp.·December 8, 2021
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·May 1, 2019
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·August 28, 2019
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·August 28, 2019
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.
FDA Enforcement
Class II
·Terminated·Thoratec Corp.·January 8, 2020
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
FDA Enforcement
Class II
·Ongoing·Thoratec Corp.·October 11, 2023