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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 MICRA TRANSCATHETER PACEMAKER SYSTEM
Generic NameLeadless pacemaker
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP150033
Date Received09/17/2015
Decision Date04/06/2016
Product Code PNJ 
Docket Number 16M-1125
Notice Date 04/12/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT02004873
Expedited Review Granted? Yes
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Micra Transcatheter Pacemaker System (Pacemaker Model MC1VR01 and Programmer Application Software model SW022 Version 1.1). This device is indicated for use in patients who have experienced one or more of the following conditions:• symptomatic paroxysmal or permanent high-grade AV block in the presence of AF• symptomatic paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy• symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapyRate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: 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 S118 S119 S120 S121 S122 S123 
S124 S125 S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 
S136 S137 S138 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 S183 S184 
S185 S187 S188 S189 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  S001 S002 S003 
S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 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 
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