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| Trade Name | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION |
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| Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
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| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
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| PMA Number | P010031 |
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| Date Received | 05/04/2001 |
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| Decision Date | 06/26/2002 |
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| Product Code | |
| Docket Number | 02M-0381 |
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| Notice Date | 08/26/2002 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the insync icd model 7272 dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy and the model 9969 application software. The insync icd model 7272 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction less than or equal to 35% and a qrs duration greater than or equal to 130 ms. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 S017 S018
S019 S020 S022 S023 S024 S025
S026 S028 S029 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 S060 S061 S062 S063
S064 S065 S066 S067 S068 S069
S070 S071 S072 S073 S074 S075
S076 S077 S078 S079 S080 S081
S082 S083 S084 S085 S086 S087
S088 S089 S090 S091 S092 S093
S095 S096 S097 S098 S099 S100
S101 S102 S103 S104 S105 S106
S107 S108 S109 S110 S111 S112
S113 S114 S115 S116 S117 S118
S120 S121 S122 S123 S124 S125
S126 S127 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 S162
S163 S164 S165 S167 S168 S169
S170 S171 S172 S173 S174 S175
S176 S177 S178 S179 S180 S181
S182 S183 S184 S185 S186 S187
S188 S189 S191 S192 S193 S194
S195 S196 S197 S198 S199 S201
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S226 S227 S228 S229 S230 S231
S232 S233 S234 S235 S236 S237
S238 S239 S242 S243 S244 S245
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S264 S265 S266 S267 S268 S269
S270 S271 S272 S273 S275 S276
S277 S278 S279 S280 S281 S283
S284 S285 S286 S287 S288 S289
S290 S291 S292 S293 S294 S295
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S303 S304 S305 S306 S307 S308
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S348 S349 S351 S352 S353 S354
S355 S356 S357 S358 S359 S360
S362 S364 S365 S366 S367 S368
S369 S370 S371 S374 |
