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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)
Applicant
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
st. paul, MN 55112-5798
PMA NumberP110042
Date Received12/23/2011
Decision Date09/28/2012
Product Codes NVY  LWS 
Docket Number 12M-1048
Notice Date 11/01/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00399217
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 
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