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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.
 
DeviceANTHEM AND FRONTIER II CRT-P'S
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP030035
Date Received08/29/2003
Decision Date05/13/2004
Product Code NKE 
Docket Number 04M-0250
Notice Date 05/26/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM. THE FRONTIER BIVENTRICULAR PACING SYSTEM IS INDICATED FOR MAINTAINING SYNCHRONY OF THE LEFT AND RIGHT VENTRICLES IN PATIENTS WHO HAVE UNDERGONE AN AV NODAL ABLATION FOR CHRONIC ATRIAL FIBRILLATION AND HAVE NYHA CLASS II OR III HEART FAILURE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S006 S007 S008 S009 S010 S011 S012 S015 
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 S061 S062 S063 S064 
S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S081 S082 S083 S084 S085 S086 S087 S088 S089 
S090 S091 S093 S094 S095 S096 S097 S098 S099 S100 S101 S102 
S103 S104 S105 S107 S108 S109 S110 S111 S112 S113 S114 S115 
S116 S117 S118 S119 S120 S121 S122 S123 S124 S125 S126 S127 
S128 S129 S131 S132 S133 S134 S135 S136 S137 S138 S139 S140 
S141 S142 S143 S144 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 S183 S184 S185 S186 S187 S188 S189 
S190 S191 S192 S193 S194 S195 S196 S197 S200 
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