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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.
 
DeviceTUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP050023
Date Received07/11/2005
Decision Date08/10/2006
Product Code MRM 
Docket Number 06M-0367
Notice Date 09/08/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TUPOS LV/ATX CRT-D, KRONOS LV-T CRT-D, 505.U PROGRAMMER SOFTWARE FOR THE ICS 3000, A-K00.7.U PROGRAMMER SOFTWARE FOR THE EPR/TMS 1000PLUS AND COROX OTW STEROID LEAD. THE TUPOS LV/ATX AND KRONOS LV-T CRT-DS ARE INDICATED FOR USE IN PATIENTS WITH ALL OF THE FOLLOWING CONDITIONS: 1) INDICATED FOR ICD THERAPY; 2) RECEIVING OPTIMIZED AND STABLE CONGESTIVE HEART FAILURE (CHF) DRUG THERAPY; 3) SYMPTOMATIC CHF (NYHA CLASS III/IV AND LVEF <=35%); AND 4) INTRAVENTRICULAR CONDUCTION DELAY (QRS DURATION >=130 MS). THE TUPOS LV/ATX IS ALSO INDICATED FOR PATIENTS WHO, IN ADDITION TO AN INDICATION FOR A CRT-D DEVICE, HAVE ATRIAL TACHYARRHYTHMIAS OR ARE AT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE COROX OTW STEROID LEADS ARE INTENDED FOR IMPLANTATION VIA THE CORONARY VEINS TO PROVIDE LONG TERM CARDIAC PACING WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 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 S143 S144 S145 S146 S147 S148 
S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 S159 S160 
S163 S164 S165 S166 S167 S168 S169 S170 S171 S172 S173 S174 
S175 S176 S177 S178 S182 
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