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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 NameHEARTWARE VENTRICULAR ASSIST SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantHEARTWARE, INC.
PMA NumberP100047
Supplement NumberS008
Date Received11/29/2012
Decision Date01/07/2013
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Implementation of a modified polishing/ buffing process for the coated impellers, which are used with the device.
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