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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
Recalls CDRH Recalls
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 S014 S015 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S041 
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