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: REVO MRI SURESCAN IPG AND PACING SYSTEM
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: Medtronic, Inc; 8200 Coral Sea Street NE; Mounds View, MN 55112
• PMA Number: P090013
• Date Received: 06/09/2009
• Decision Date: 02/08/2011
• Product Codes: LWP NVN
• Docket Number: 11M-0105
• Notice Date: 02/24/2011
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00433654
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE REVO MRISURESCAN PACING SYSTEM, WHICH CONSISTS OF THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG, THE MEDTRONIC CAPSUREFIX MRI¿ SURESCAN¿ 5086MRI LEAD, AND THE REVO MRI¿ SOFTWARE APPLICATION MODEL SW018. THIS SYSTEM IS INDICATED AS FOLLOWS:THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A REVO MRI SURESCAN IPG IMPLANTED WITH TWO CAPSURE FIX MRI¿SURESCAN¿ 5086MRI LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THE MRI ENVIRONMENT.THE MEDTRONIC REVO MRI¿ SURESCAN¿ MODEL RVDR01 IPG IS INDICATED FOR THEFOLLOWING:1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RALESCONCURRENT WITH INCREASES IN ACTIVITY;2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE:A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-DEGREE OR THIRD-DEGREE AV BLOCK;B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; ANDD) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOMEFORMS OF SYMPTOMATIC TACHYARRHYTHMIAS...(SEE APPROVAL ORDER FOR ADD'L DETAIL)

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S089 S090 S023 S024 S026 S027 S028 S029 S030 S037 S038 S039 ; S040 S041 S042 S043 S187 S165 S166 S167 S168 S169 S170 ; S171 S173 S172 S174 S066 S067 S068 S069 S070 S225 S226 S123 ; S124 S125 S126 S127 S063 S064 S065 S044 S045 S047 S048 S049 ; S140 S141 S109 S110 S111 S202 S203 S204 S205 S206 S207 S208 ; S151 S152 S153 S154 S155 S156 S081 S211 S212 S213 S214 S215 ; S231 S232 S233 S244 S245 S246 S247 S248 S252 S253 S254 S255 ; S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 S013 ; S015 S016 S017 S018 S031 S032 S033 S034 S035 S019 S020 S021 ; S022 S054 S055 S056 S057 S058 S059 S060 S061 S071 S072 S073 ; S074 S075 S082 S083 S091 S092 S093 S095 S096 S097 S112 S113 ; S114 S115 S157 S158 S159 S160 S161 S188 S189 S190 S191 S192 ; S193 S194 S195 S142 S143 S145 S144 S146 S175 S176 S177 S178 ; S179 S180 S181 S128 S129 S130 S131 S132 S098 S099 S100 S102 ; S103 S104 S116 S117 S118 S119 S120 S121 S209 S210 S076 S077 ; S078 S079 S080 S162 S163 S164 S196 S197 S198 S199 S200 S201 ; S050 S051 S053 S147 S148 S149 S150 S084 S085 S086 S087 S088 ; S182 S183 S184 S185 S186 S133 S134 S135 S136 S137 S138 S139 ; S108 S216 S217 S218 S236 S237 S238 S239 S219 S220 S221 S222 ; S223 S224 S259 S260 S261 S227 S228 S229 S230 S249 S250 S251 ; S240 S241 S242 S243 S234 S235 S256 S257 S258 S105 S106 S107 ; S270 S263 S298 S299 S305 S294 S295 S311 S312 S313 S319 S325 ; S315 S321 S322 S323 S326 S327 S328 S329 S265 S266 S287 S288 ; S281 S282 S283 S284 S262 S275 S276 S277 S278 S279 S280 S267 ; S268 S269 S289 S285 S286 S271 S272 S273 S274 S264 S292 S293 ; S300 S301 S296 S302 S303 S304 S309 S306 S307 S308 S290 S291 ; S324 S320 S314 S316 S317 S318 S310 S330