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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 NameHEART WARE VENTRICULAR ASSIST SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantHEARTWARE, INC.
PMA NumberP100047
Supplement NumberS033
Date Received11/18/2013
Decision Date02/13/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of a new formulation of the thermoplastic vulcanizate (tpz) material used in the manufacture of the monitor data cable, battery pack cable, dc adaptor input cable, and alarm silence adaptor components of the device.
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