| Z-2052-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240 | March 30, 2017 |
| Z-2053-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130240112 | March 30, 2017 |
| Z-2051-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112 | March 30, 2017 |
| Z-229-2014 | Class I | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical de | March 4, 2014 |
| Z-1230-2014 | Class I | Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha | March 4, 2014 |
| Z-1228-2014 | Class I | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulate | March 4, 2014 |
| Z-1227-2014 | Class I | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) | March 4, 2014 |