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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-2PLUS PORTABLE VAD DRIVER
Classification Nameventricular (assisst) bypass
Generic Nameventricular assist device
ApplicantTHORATEC CORP.
PMA NumberP870072
Supplement NumberS043
Date Received02/12/2010
Decision Date03/30/2010
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a firmware modification to the occlusion alarm algorithm in the tlc-iiplus.
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