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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
Predetermined Change Control Plan AuthorizedNo
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: S080 S081 S082 S083 S066 S067 S068 S069 S110 S058 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 
S059  S075 S076 S077 S078 S079 S001 S002 S003 S004 S005 
S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 
S018 S019 S020 S021 S022 S023 S024 S084 S085 S086 S087 S062 
S060 S061 S070 S071 S072 S073 S074 S063 S064 S065 S095 S096 
S097 S098 S104 S122 S123 S129 S130 S133 S134 S150 S151 S124 
S125 S139 S140 S114 S115 S177 S157 S153 S154 S155 S181 S182 
S183 S189 S197 S198 S200 S201 S193 S194 S092 S093 S094 S107 
S108 S109 S099 S100 S101 S102 S103 S111 S088 S089 S090 S091 
S105 S106 S138 S117 S118 S119 S120 S121 S127 S128 S141 S142 
S143 S147 S148 S149 S135 S136 S137 S126 S144 S145 S146 S131 
S132 S112 S113 S116 S160 S161 S162 S163 S164 S165 S172 S184 
S152 S185 S186 S187 S188 S173 S174 S175 S176 S156 S178 S179 
S180 S166 S167 S168 S169 S158 S159 S170 S171 S192 S199 S195 
S196 S190 S191 
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