Premarket Approval (PMA)

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.

• Device: MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
• Generic Name: Leadless pacemaker
• Regulation Number: 870.3610
• Applicant: MEDTRONIC Inc.; 8200 CORAL SEA STREET NE; MS MV S11; MOUNDS VIEW, MN 55112
• PMA Number: P150033
• Date Received: 09/17/2015
• Decision Date: 04/06/2016
• Product Code: PNJ
• Docket Number: 16M-1125
• Notice Date: 04/12/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT02004873
• Expedited Review Granted?: Yes
• Combination Product: Yes
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S005 S006 S013 S014 S021 S022 S007 S008 ; S009 S010 S024 S025 S004 S015 S016 S017 S018 S019 S020 S011 ; S012 S023 S032 S033 S029 S030 S031 S038 S039 S040 S041 S027 ; S054 S066 S067 S068 S047 S048 S073 S074 S075 S076 S077 S078 ; S079 S080 S118 S119 S120 S121 S122 S123 S124 S125 S126 S151 ; S152 S153 S154 S155 S156 S157 S158 S159 S160 S161 S113 S114 ; S115 S116 S095 S096 S097 S098 S099 S136 S165 S166 S172 S173 ; S174 S175 S176 S179 S180 S026 S034 S035 S036 S028 S049 S055 ; S081 S082 S083 S084 S085 S086 S087 S056 S057 S058 S059 S088 ; S089 S090 S091 S069 S070 S071 S072 S060 S061 S062 S063 S064 ; S065 S042 S043 S044 S045 S046 S050 S051 S052 S053 S134 S135 ; S092 S093 S094 S142 S143 S144 S145 S146 S147 S106 S107 S108 ; S109 S110 S111 S112 S162 S163 S164 S167 S168 S169 S170 S171 ; S127 S128 S129 S130 S131 S132 S133 S137 S138 S140 S141 S148 ; S149 S150 S100 S101 S102 S103 S104 S105 S183 S184 S186 S187 ; S188 S189 S177 S178 S181 S182