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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.
 
DeviceMEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
Generic NameDrug eluting permanent left ventricular (lv) pacemaker electrode
ApplicantMEDTRONIC Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432
PMA NumberP080006
Date Received03/14/2008
Decision Date04/07/2009
Product Code OJX 
Docket Number 09M-0182
Notice Date 04/10/2009
Advisory Committee Cardiovascular
Clinical TrialsNCT00271544
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE ATTAIN ABILITY MODEL 4196 LEAD. THE ATTAIN ABILITY MODEL 4196 STEROID ELUTING, DUAL ELECTRODE, IS-1TRANSVENOUS LEAD IS INDICATED FOR CHRONIC PACING AND SENSING IN THE LEFT VENTRICLE VIA THE CARDIAC VEIN, WHEN USED IN CONJUNCTION WITH A COMPATIBLE MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY (CRT) SYSTEM. EXTENDED BIPOLAR PACING IS AVAILABLE USING THIS LEAD IN COMBINATION WITH A COMPATIBLE CRT-D SYSTEM AND RV DEFIBRILLATION LEAD OR WITH A COMPATIBLE CRT-P SYSTEM AND RV PACING LEAD.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S051 S052 S053 S054 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 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 S142 S143 S144 S145 
S146 S147 S148 S149 S150 S151 S152 S153 S154 S155 S156 S157 
S158 S159 S160 S161 S162 S163 S164 S165 S166 S167 S168 S169 
S170 S171 S172 S173 S174 S175 S176 S177 S178 S179 S180 S181 
S182 
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