• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardioverter defibrillator system
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP980016
Date Received05/11/1998
Decision Date10/09/1998
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 98M-0907
Notice Date 12/07/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic(r) model 7271 gem(tm) dr dual chamber implantable cardioverter defibrillator system with mdoel 9960 (gem(tm) dr) application software, medtronic(r) model 6940 capsurefix(r) lead and model 9466 patient magnet. This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted. ).
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 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 S037 
S038 S039 S040 S041 S042 S043 S044 S045 S046 
S047 S048 S050 S051 S052 S053 S054 S055 S056 
S058 S059 S060 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 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 S117 S118 S119 S120 S121 S122 
S123 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 
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 S186 S187 
S188 S189 S191 S192 S193 S194 S195 S196 S197 
S198 S199 S201 S202 S203 S204 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 S232 S233 S234 S235 S236 
S237 S238 S239 S240 S241 S243 S244 S245 S246 
S247 S248 S249 S250 S251 S252 S253 S254 S255 
S256 S257 S258 S259 S260 S261 S262 S263 S264 
S265 S266 S267 S268 S269 S270 S271 S272 S273 
S274 S275 S276 S277 S278 S279 S280 S281 S282 
S283 S284 S285 S288 S289 S290 S291 S292 S293 
S294 S295 S296 S297 S298 S299 S300 S301 S302 
S303 S304 S305 S306 S307 S308 S309 S310 S311 
S312 S313 S314 S315 S316 S317 S318 S319 S321 
S322 S323 S324 S325 S326 S327 S328 S330 S331 
S332 S333 S334 S335 S336 S337 S338 S339 S340 
S341 S342 S343 S344 S345 S346 S347 S348 S349 
S351 S352 S353 S354 S355 S356 S357 S358 S360 
S361 S362 S363 S364 S365 S366 S367 S368 S369 
S370 S371 S372 S373 S374 S375 S376 S377 S378 
S379 S380 S381 S382 S383 S384 S386 S387 S388 
S389 S390 S391 S392 S393 S394 S395 S396 S397 
S398 S399 S400 S401 S402 S403 S404 S405 S406 
S407 S408 S409 S410 S411 S412 S413 S414 S415 
S416 S417 S418 S419 S420 S421 S422 S423 S424 
S425 S426 S427 S428 S429 S430 S431 S432 S433 
S435 S436 S437 S438 S439 S440 S441 S442 S443 
S445 S446 S447 S448 S449 S450 S451 S452 S453 
S454 S455 S456 S457 S458 S459 S460 S461 S462 
S463 S464 S465 S466 S467 S468 S469 S470 S471 
S472 S473 S474 S475 S476 S477 S478 S479 S480 
S481 S482 S483 S484 S485 S486 S487 S488 S489 
S490 S491 S493 S494 S495 S496 S497 S498 S499 
S501 S503 S504 S505 S506 S507 
-
-