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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHEARTWARE VENTRICULAR ASSIST SYSTEM
Generic NameVentricular (assist) bypass
ApplicantMedtronic
8200 Coral SeaSt. N.E.
Mounds View, MN 55112
PMA NumberP100047
Date Received12/28/2010
Decision Date11/20/2012
Product Code DSQ 
Docket Number 12M-1184
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00751972
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 S055 S056 S057 S060 S061 S062 
S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 
S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 
S087 S088 S089 S090 S091 S092 S093 S094 S095 S096 S097 S098 
S099 S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 
S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 S122 
S123 S124 S125 S126 S127 S129 S130 S131 S132 S133 S134 S135 
S136 S137 S138 S139 S140 S141 S142 S143 S144 S145 S147 S148 
S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 S159 S161 
S162 S163 S164 S166 S167 S168 S169 S170 S171 S172 S173 S174 
S175 S176 S177 S178 S179 S180 S181 S182 S183 S184 S185 S186 
S188 S189 S190 S191 S192 S193 S194 S195 S196 S197 S198 S199 
S200 S201 S202 S204 S205 S206 S207 S208 S209 S210 S211 S212 
S214 
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