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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 LEFT VENTRICULAR ASSIST DEVICE SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantHEARTWARE, INC.
PMA NumberP100047
Supplement NumberS044
Date Received05/29/2014
Decision Date06/27/2014
Product Code
DSQ[ Registered Establishments with DSQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updates to the instructions for use and patient manual of the device to include information related to battery performance.
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