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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.
 
DeviceCONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantGUIDANT CORP.
4100 HAMLINE AVENUE NORTH
ST. PAUL, MN 55112-5798
PMA NumberP030005
Date Received03/24/2003
Decision Date01/26/2004
Product Code NKE 
Docket Number 04M-0064
Notice Date 02/24/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CONTAK RENEWAL TR. THE DEVICE IS INDICATED S FOLLOWS: THE CONTAK RENEWAL TR PULSE GENERATOR IS INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY (AS DEFINED IN THE CLINICAL TRIALS SECTION). THE DEVICE PROVIDES ATRIAL-VENTRICULAR TRACKING MODES TO HELP PRESERVE AV SYNCHRONY, AND ADAPTIVE-RATE PACING FOR PATIENTS WHO WOULD BENEFIT FROM ADJUSTED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S018 S019 S020 S021 S022 S023 S024 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S037 S039 S040 S041 
S042 S043 S044 S046 S047 S048 S049 S050 S051 S052 S053 S054 
S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078 S079 
S080 S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 S092 
S093 S094 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 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 S178 S179 
S180 S181 S182 S183 S184 S185 S186 S187 S188 S189 S190 S191 
S192 S193 S194 S195 S196 S197 S198 S199 S200 S201 S202 S203 
S204 S205 S206 S207 S208 S209 S210 S211 S212 S213 S214 S215 
S216 S217 S218 S219 S220 S221 S222 S223 S224 S225 S226 S227 
S228 S229 S230 S231 S232 S233 S234 S235 
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