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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.
 
DeviceMEDTRONIC COREVALVE SYSTEM
Generic NameAortic valve, prosthesis, percutaneously delivered
ApplicantMedtronic, Inc.
710 Medtronic Parkway
Minneapolis,, MN 55432
PMA NumberP130021
Date Received07/22/2013
Decision Date01/17/2014
Product Code NPT 
Docket Number 14M-0166
Notice Date 02/04/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT01240902
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Medtronic CoreValve™ System. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ? 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ? 50% at 30 days).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S006 S007  S018 S023 S026 S027 S028 S037 S002 S008 S015 
S016 S017 S011 S012 S005 S009 S010 S003 S004 S013 S014 S019 
S025 S020 S039 S021 S022 S029 S030 S031 S032 S033 S034 S035 
S036 S024 S046 S047 S048 S050 S051 S038 S058 S064 S065 S066 
S067 S068 S078 S079 S060 S071 S072 S073 S054 S103 S104 S121 
S122 S123 S125 S126 S100 S101 S102 S088 S089 S090 S091 S092 
S093 S110 S111 S112 S113 S130 S131 S132 S133 S134 S135 S138 
S139 S042 S052 S049 S043 S045 S040 S041 S081 S059 S069 S070 
S074 S075 S076 S077 S084 S061 S062 S063 S055 S056 S057 S053 
S080 S106 S107 S116 S117 S118 S127 S128 S129 S146 S147 S148 
S136 S137 S082 S083 S094 S095 S096 S097 S098 S085 S086 S087 
S119 S120 S108 S109 S105 S114 S115 S151 S152 S153 S154 S155 
S140 S141 S142 S143 S144 S145 S149 S150 S156 S157 S158 S159 
S160 S161 
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