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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.
 
DeviceSTRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP070008
Date Received03/12/2007
Decision Date05/12/2008
Product Code NKE 
Docket Number 08M-0335
Notice Date 06/05/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE STRATOS LV CRT-P AND STRATOS LV-T CRT-P WITH 702.U PROGRAMMER SOFTWARE FOR THE ICS 3000 AND COROX OTW BP LEAD AND COROX OTW-S BP LEAD. THE STRATOS LV CRT-P AND THE STRATOS LV-T CRT-P ARE INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS II1/IV), INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF< 35%) AND QRS > 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. THE COROX OTW BP AND COROX OTW-S BP LEFT VENTRICULAR PACING LEADS ARE BIPOLAR STEROID-ELUTING LEADS, INTENDED FOR PERMANENT IMPLANTATION IN THE LEFT VENTRICLE VIA THE CORONARY VEINS TO PROVIDE PACING AND/OR SENSING WHEN USED IN CONJUNCTION WITH A COMPATIBLE IS-1 PULSE GENERATOR.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S041 S042 S043  S051 S021 S023 S024 S025 S026 S027 S032 
S035 S048 S049 S050 S044 S054 S064 S065 S066 S033 S030 S031 
S011 S009 S010 S019 S020 S016 S017 S070 S075 S079 S080 S028 
S055 S056 S057 S067 S036 S037 S038 S039 S059 S060 S061 S034 
S052 S053 S069 S029 S058 S068 S062 S063 S045 S046 S047 S012 
S013 S018 S015 S006 S001 S002 S003 S004 S005 S014 S071 S072 
S082 S083 S086 S073 S074 S081 S077 S076 S007 S008 S088 S094 
S095 S096 S092 S093 S084 S085 S090 S091 S101 S102 S116 S105 
S113 S114 S115 S139 S140 S141 S128 S129 S122 S123 S124 S125 
S145 S146 S147 S148 S150 S097 S089 S087 S118 S119 S103 S104 
S100 S110 S111 S108 S109 S106 S107 S117 S099 S098 S133 S134 
S137 S142 S143 S144 S151 S152 S153 S154 S155 S149 S120 S121 
S126 S127 S138 S135 S136 S132 
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