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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.
 
DeviceSUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBOSTON SCIENTIFIC CORPORATION
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP110042
Date Received12/23/2011
Decision Date09/28/2012
Product Codes LWS NVY 
Docket Number 12M-1048
Notice Date 11/01/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00399217
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THIS DEVICE IS INDICATED TO PROVIDE DEFIBRILLATION THERAPY FOR THE TREATMENT OF LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS INPATIENTS WHO DO NOT HAVE SYMPTOMATIC BRADYCARDIA, INCESSANT VENTRICULAR TACHYCARDIA, OR SPONTANEOUS, FREQUENTLY RECURRING VENTRICULAR TACHYCARDIA THAT IS RELIABLY TERMINATED WITH ANTITACHYCARDIA PACING.
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 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S037 
S038 S039 S040 S041 S042 S043 S045 S049 S050 S051 S052 S053 
S055 S056 S057 S058 S059 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 S128 S129 S130 S131 S132 S133 S134 S135 S136 S137 S138 
S139 S140 S141 S142 S143 S144 S145 S146 S147 S148 S149 S150 
S151 S152 S153 S154 S155 S156 S157 S158 S159 S160 S161 S162 
S163 S164 S165 S166 S167 S168 S169 S170 S171 S172 S173 S174 
S175 S176 S177 S178 S179 S180 S181 S182 S183 S184 S185 S186 
S187 S188 S189 S190 S191 S192 S194 
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