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: CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Abbott Medical; 15900 Valley View Court; Sylmar, CA 91335
• PMA Number: P910023
• Date Received: 04/23/1991
• Decision Date: 04/30/1993
• Product Code: LWS
• Docket Number: 93M-0216
• Notice Date: 07/22/1993
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Cadence® Tiered Therapy Defibrillator System. This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tacharrhythmias. In addition, the Cadence® can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is antitachycardia pacing; the defibrillation capabilities of the device provide high energy therapy in the event that the arrhythmia accelerates. The Cadence® is intended for use with the defibrillation lead systems with which it has been tested: Ventritex epicardial defibrillation leads, and commercially available CPI defibrillation patch leads and superior vena cava (SVC) spring leads. When used with the CPI patch lead or SVC leads, the Cadence® is intended for use as a replacement for CPI automatic implantable cardioverter defibrillators.

• Supplements: S343 S325 S314 S001 S002 S003 S004 S005 S006 S007 S008 ; S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 ; S022 S023 S024 S025 S334 S335 S336 S337 S338 S252 S253 S254 ; S255 S256 S257 S258 S260 S261 S262 S263 S264 S265 S266 S267 ; S268 S269 S270 S271 S272 S273 S274 S275 S276 S294 S364 S365 ; S309 S310 S353 S354 S323 S324 S357 S297 S298 S299 S300 S287 ; S288 S289 S290 S291 S293 S213 S214 S076 S032 S033 S069 S071 ; S051 S052 S089 S090 S091 S092 S093 S094 S095 S097 S098 S099 ; S100 S101 S102 S163 S164 S165 S166 S050 S061 S062 S143 S144 ; S145 S146 S150 S151 S152 S153 S154 S155 S156 S157 S158 S121 ; S122 S123 S124 S125 S126 S127 S128 S228 S229 S230 S044 S045 ; S204 S205 S206 S207 S208 S210 S211 S212 S198 S199 S200 S201 ; S202 S203 S251 S068 S232 S233 S234 S235 S236 S237 S238 S239 ; S240 S241 S242 S060 S116 S117 S118 S120 S043 S038 S039 S040 ; S041 S042 S067 S083 S084 S085 S086 S087 S088 S113 S114 S115 ; S132 S133 S134 S135 S136 S137 S138 S139 S140 S141 S142 S075 ; S367 S369 S372 S377 S378 S384 S385 S034 S035 S036 S037 S047 ; S048 S049 S026 S027 S028 S029 S030 S031 S277 S278 S279 S280 ; S281 S282 S321 S322 S327 S328 S329 S330 S331 S332 S344 S345 ; S358 S311 S312 S313 S355 S302 S303 S304 S306 S315 S316 S318 ; S319 S339 S340 S341 S342 S366 S295 S296 S285 S346 S347 S348 ; S349 S351 S352 S359 S360 S361 S362 S363 S333 S307 S356 S320 ; S063 S064 S065 S066 S077 S078 S079 S080 S081 S103 S104 S107 ; S108 S109 S110 S111 S112 S053 S054 S055 S056 S057 S058 S072 ; S073 S167 S168 S169 S183 S184 S185 S186 S187 S188 S215 S216 ; S217 S218 S219 S220 S243 S244 S245 S246 S247 S248 S249 S250 ; S170 S171 S172 S173 S231 S221 S222 S223 S224 S225 S226 S189 ; S190 S191 S192 S129 S130 S131 S159 S160 S161 S162 S174 S175 ; S176 S177 S178 S179 S180 S181 S182 S227 S370 S376 S371 S386 ; S387 S388 S373 S374 S375 S379 S380 S381 S382 S383 S193 S194 ; S195 S196 S197 S397 S398 S410 S409 S404 S405 S416 S421 S422 ; S423 S428 S425 S426 S412 S413 S432 S439 S440 S437 S443 S450 ; S451 S452 S392 S393 S394 S411 S399 S400 S401 S402 S403 S395 ; S396 S406 S407 S408 S389 S390 S391 S417 S433 S424 S427 S435 ; S419 S420 S418 S414 S415 S429 S430 S431 S445 S449 S458 S453 ; S454 S434 S438 S436 S446 S447 S448 S441 S442 S444 S462 S456 ; S457 S459 S460