|Trade Name||THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular assist device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of the vad system in the home environment and for the addition of two accessories for the thoratec vad system: the mobile computer and the car power adapter. The device, as modified, will be marketed under the trade name thoratec paracorporeal ventricular assist device system and tlc-ii portable vad driver. The pvad is indicated for use in bridge to transplant patients who meet all of the following criteria: candidate for cardiac transplantation, imminent risk of dying before donor heart procurement, dependence on, or incomplete response to, continued vasopressor support. It is also indicated for post cardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The tlc-ii portable pneumatic driver is intended for use both inside and outside the hospital or for transportation of vad patients via ground ambulance.