|Trade Name||TLC-II PORTABLE VAD DRIVER|
|Classification Name||ventricular (assisst) bypass|
|Generic Name||ventricular assist device|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the tlc-ii portable vad driver, including the addition of a scroll compressor, electronic rvad pressure regulator, longer pneumatic leads removal of contraindication against patients requiring high rvad driver pressures and/or long ejection times, and associated hardware and software changes.