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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTLC-II PORTABLE VAD DRIVER
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS035
Date Received09/14/2006
Decision Date01/21/2009
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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.
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