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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:  S031 S033 S045 S070 S071 S072 S073 S074 S062 S063 S064 
S065 S135 S079 S080 S081 S082 S051 S052 S053 S055 S056 S032 
S096 S097 S098 S141 S057 S027 S028 S029 S034 S035 S037 S038 
S039 S049 S120 S121 S122 S153 S154 S155 S169 S177 S158 S159 
S160 S161 S162 S163 S164 S165 S041 S042 S151 S152 S040 S043 
S050 S013 S014 S015 S002 S003 S008 S016 S017 S018 S019 S020 
S021 S009 S010 S011 S012 S004 S005 S058 S006 S007 S001 S136 
S137 S126 S172 S173 S174 S175 S157 S186 S187 S188 S176 S059 
S085 S086 S087 S066 S067 S068 S069 S060 S061 S075 S076 S077 
S078 S083 S084 S088 S089 S090 S022 S023 S024 S025 S026 S166 
S167 S168 S107 S108 S109 S110 S095 S091 S112 S113 S114 S127 
S142 S143 S144 S145 S115 S116 S180 S181 S198 S199 S156 S178 
S179 S170 S171 S147 S148 S149 S150 S185 S197 S193 S189 S190 
S182 S183 S184 S191 S192 S194 S195 S104 S105 S111 S106 S092 
S093 S094 S099 S100 S101 S102 S103 S138 S139 S140 S128 S129 
S130 S146 S131 S132 S133 S123 S124 S125 S117 S118 S119 S134 
S196 
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