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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHEARTWARE VENTRICULAR ASSIST SYSTEM
Classification Nameventricular (assisst) bypass
ApplicantHEARTWARE, INC.
PMA NumberP100047
Date Received12/28/2010
Decision Date11/20/2012
Product Code
DSQ[ Registered Establishments with DSQ ]
Docket Number 12M-1184
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00751972
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the heartware ventricular assist system (vas). This device is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The heart ware vas is designed for in-hospital and out-of-hospital settings, including transportation via fixed wing aircraft or helicopter.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S015 S017 S018 
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