VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P960040 S444

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To remove a redundant process monitor inspection on the tachy battery stack's discrete separator

DeviceVENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2019-11-07
Decision Date2019-11-15
PMAP960040
SupplementS444
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P960040Original Filing
S444 2019-11-07 30-day Notice
S443 2019-10-21 30-day Notice
S442 2019-09-10 30-day Notice
S441 2019-07-22 Real-time Process
S440 2019-06-20 Real-time Process
S439 2019-05-31 30-day Notice
S438
S437
S436 2019-03-20 Real-time Process
S435 2019-03-11 30-day Notice
S434
S433 2019-02-01 30-day Notice
S432 2018-12-26 30-day Notice
S431 2018-12-03 Real-time Process
S430 2018-10-19 30-day Notice
S429 2018-10-05 30-day Notice
S428 2018-08-30 30-day Notice
S427 2018-06-27 30-day Notice
S426 2018-06-22 Normal 180 Day Track No User Fee
S425 2018-05-02 30-day Notice
S424 2018-04-09 30-day Notice
S423 2018-03-26 30-day Notice
S422 2018-02-16 30-day Notice
S421 2018-02-12 Real-time Process
S420 2018-02-02 30-day Notice
S419 2018-01-19 30-day Notice
S418 2018-01-18 Real-time Process
S417 2017-12-22 30-day Notice
S416 2017-12-22 30-day Notice
S415 2017-12-19 30-day Notice
S414 2017-12-14 Real-time Process
S413 2017-11-21 30-day Notice
S412 2017-11-21 30-day Notice
S411 2017-11-20 30-day Notice
S410 2017-11-13 30-day Notice
S409 2017-11-02 30-day Notice
S408 2017-10-20 Real-time Process
S407 2017-09-28 30-day Notice
S406 2017-09-15 Real-time Process
S405 2017-09-15 Normal 180 Day Track No User Fee
S404 2017-09-14 30-day Notice
S403 2017-09-05 30-day Notice
S402 2017-08-30 30-day Notice
S401 2017-08-04 30-day Notice
S400 2017-07-31 Normal 180 Day Track No User Fee
S399 2017-08-02 30-day Notice
S398 2017-07-17 Real-time Process
S397 2017-06-07 30-day Notice
S396 2017-05-31 Normal 180 Day Track No User Fee
S395 2017-05-26 Normal 180 Day Track
S394 2017-05-23 30-day Notice
S393 2017-05-22 Real-time Process
S392 2017-05-10 30-day Notice
S391 2017-04-03 Normal 180 Day Track
S390 2017-03-06 Real-time Process
S389 2017-02-17 Real-time Process
S388 2017-01-23 30-day Notice
S387 2016-12-19 30-day Notice
S386 2016-11-22 Real-time Process
S385 2016-10-28 Normal 180 Day Track
S384 2016-10-26 Normal 180 Day Track
S383 2016-10-21 Real-time Process
S382 2016-09-16 30-day Notice
S381 2016-09-12 30-day Notice
S380 2016-09-02 30-day Notice
S379 2016-08-17 30-day Notice
S378 2016-07-07 30-day Notice
S377 2016-07-07 30-day Notice
S376 2016-07-01 Real-time Process
S375 2016-06-27 30-day Notice
S374 2016-06-16 Normal 180 Day Track
S373 2016-05-26 30-day Notice
S372 2016-05-04 30-day Notice
S371 2016-04-27 30-day Notice
S370 2016-04-21 Real-time Process
S369 2016-04-11 30-day Notice
S368 2016-03-23 30-day Notice
S367 2016-03-23 30-day Notice
S366 2016-02-29 30-day Notice
S365 2016-02-17 Real-time Process
S364 2016-02-11 30-day Notice
S363 2016-01-20 Real-time Process
S362 2015-12-21 Real-time Process
S361 2015-11-13 135 Review Track For 30-day Notice
S360 2015-11-09 Normal 180 Day Track
S359 2015-11-09 30-day Notice
S358 2015-11-04 30-day Notice
S357 2015-09-30 30-day Notice
S356 2015-09-23 30-day Notice
S355 2015-09-17 30-day Notice
S354 2015-09-02 Real-time Process
S353 2015-07-29 30-day Notice
S352 2015-07-13 30-day Notice
S351 2015-07-13 Real-time Process
S350 2015-07-08 30-day Notice
S349
S348
S347 2015-05-28 30-day Notice
S346 2015-05-18 30-day Notice
S345 2015-04-27 Real-time Process
S344 2015-03-25 30-day Notice
S343 2015-02-05 30-day Notice
S342 2015-01-29 30-day Notice
S341 2014-12-16 30-day Notice
S340 2014-12-15 30-day Notice
S339 2014-11-24 30-day Notice
S338 2014-11-24 30-day Notice
S337 2014-11-20 Real-time Process
S336 2014-10-15 Normal 180 Day Track
S335 2014-10-03 30-day Notice
S334 2014-09-29 30-day Notice
S333 2014-09-17 30-day Notice
S332 2014-09-03 Real-time Process
S331 2014-08-21 30-day Notice
S330 2014-08-14 30-day Notice
S329 2014-08-14 30-day Notice
S328 2014-08-11 30-day Notice
S327
S326 2014-08-06 30-day Notice
S325 2014-08-01 30-day Notice
S324 2014-07-03 30-day Notice
S323 2014-06-30 30-day Notice
S322 2014-06-19 30-day Notice
S321 2014-06-19 30-day Notice
S320 2014-06-17 Real-time Process
S319 2014-06-09 30-day Notice
S318 2014-05-23 30-day Notice
S317 2014-05-12 30-day Notice
S316 2014-05-09 Real-time Process
S315 2014-05-05 30-day Notice
S314 2014-05-02 30-day Notice
S313 2014-04-04 30-day Notice
S312 2014-03-18 Real-time Process
S311 2014-03-14 30-day Notice
S310 2014-02-21 Real-time Process
S309 2014-02-14 30-day Notice
S308 2013-11-19 30-day Notice
S307 2013-10-29 30-day Notice
S306 2013-09-30 Normal 180 Day Track
S305 2013-09-04 30-day Notice
S304 2013-08-29 30-day Notice
S303 2013-08-20 30-day Notice
S302 2013-07-02 30-day Notice
S301
S300 2013-07-01 30-day Notice
S299 2013-06-24 30-day Notice
S298 2013-06-24 30-day Notice
S297 2013-06-17 Real-time Process
S296 2013-06-03 30-day Notice
S295 2013-05-23 30-day Notice
S294 2013-05-08 30-day Notice
S293 2013-04-03 30-day Notice
S292 2013-04-01 30-day Notice
S291 2013-03-29 30-day Notice
S290 2013-03-29 30-day Notice
S289 2013-03-20 30-day Notice
S288 2013-02-11 30-day Notice
S287 2013-02-05 30-day Notice
S286 2013-01-22 30-day Notice
S285 2013-01-17 30-day Notice
S284 2012-12-26 30-day Notice
S283 2012-12-12 30-day Notice
S282 2012-11-19 30-day Notice
S281 2012-11-08 30-day Notice
S280 2012-11-01 30-day Notice
S279 2012-10-11 30-day Notice
S278 2012-10-10 30-day Notice
S277 2012-10-09 30-day Notice
S276 2012-10-02 30-day Notice
S275 2012-10-01 30-day Notice
S274 2012-09-28 30-day Notice
S273 2012-09-24 30-day Notice
S272 2012-09-17 30-day Notice
S271 2012-09-11 30-day Notice
S270 2012-08-28 Normal 180 Day Track
S269 2012-08-28 30-day Notice
S268 2012-08-13 30-day Notice
S267 2012-07-25 30-day Notice
S266 2012-07-06 135 Review Track For 30-day Notice
S265 2012-07-26 Real-time Process
S264 2012-06-05 30-day Notice
S263 2012-05-31 30-day Notice
S262 2012-05-14 Normal 180 Day Track No User Fee
S261 2012-05-11 Real-time Process
S260 2012-05-08 30-day Notice
S259 2012-06-06 Real-time Process
S258 2012-04-27 30-day Notice
S257 2012-03-30 Real-time Process
S256 2012-03-26 30-day Notice
S255 2012-03-13 30-day Notice
S254 2012-03-01 30-day Notice
S253 2012-03-01 30-day Notice
S252 2012-02-09 Real-time Process
S251 2012-02-03 30-day Notice
S250 2011-12-29 30-day Notice
S249 2011-12-28 30-day Notice
S248 2011-12-21 30-day Notice
S247 2011-12-14 30-day Notice
S246 2011-09-26 30-day Notice
S245 2011-08-19 30-day Notice
S244 2011-05-25 30-day Notice
S243 2011-04-01 30-day Notice
S242 2011-03-18 Real-time Process
S241
S240 2010-12-20 30-day Notice
S239 2010-12-16 30-day Notice
S238 2010-09-24 Real-time Process
S237 2010-09-09 30-day Notice
S236
S235 2010-08-30 Normal 180 Day Track
S234 2010-08-23 Real-time Process
S233 2010-08-23 30-day Notice
S232 2010-08-18 30-day Notice
S231 2010-08-13 30-day Notice
S230 2010-08-09 30-day Notice
S229 2010-08-06 30-day Notice
S228 2010-08-06 30-day Notice
S227 2010-08-05 135 Review Track For 30-day Notice
S226 2010-07-15 30-day Notice
S225 2010-07-13 Real-time Process
S224 2010-08-16 Real-time Process
S223 2010-04-16 30-day Notice
S222 2010-04-16 30-day Notice
S221 2010-04-15 30-day Notice
S220 2010-03-17 30-day Notice
S219 2010-03-16 30-day Notice
S218 2010-02-16 135 Review Track For 30-day Notice
S217 2010-02-04 30-day Notice
S216
S215 2010-02-02 30-day Notice
S214 2010-03-15 Real-time Process
S213 2010-01-22 Real-time Process
S212 2009-12-16 30-day Notice
S211 2009-11-27 Special (immediate Track)
S210 2009-11-27 30-day Notice
S209 2009-11-25 30-day Notice
S208 2009-11-23 30-day Notice
S207 2009-11-19 30-day Notice
S206 2009-11-16 30-day Notice
S205 2009-09-28 30-day Notice
S204 2009-09-21 30-day Notice
S203 2009-08-18 30-day Notice
S202 2009-06-24 135 Review Track For 30-day Notice
S201 2009-06-10 30-day Notice
S200 2009-05-27 30-day Notice
S199 2009-05-22 135 Review Track For 30-day Notice
S198 2009-05-11 Normal 180 Day Track
S197 2009-05-08 Real-time Process
S196 2009-04-30 30-day Notice
S195 2009-04-30 Real-time Process
S194 2009-04-21 30-day Notice
S193 2009-04-17 Real-time Process
S192 2009-03-16 Real-time Process
S191 2009-03-13 30-day Notice
S190 2009-02-18 Real-time Process
S189 2009-02-13 30-day Notice
S188
S187 2009-01-15 30-day Notice
S186 2008-12-11 30-day Notice
S185 2008-11-21 30-day Notice
S184 2008-11-21 30-day Notice
S183 2008-11-20 30-day Notice
S182 2008-11-06 Real-time Process
S181
S180
S179 2008-10-24 30-day Notice
S178 2008-10-16 Real-time Process
S177 2008-10-01 135 Review Track For 30-day Notice
S176 2008-08-29 30-day Notice
S175 2008-08-15 Real-time Process
S174 2008-07-22 Normal 180 Day Track
S173 2008-07-23 30-day Notice
S172 2008-07-18 30-day Notice
S171 2008-07-03 Real-time Process
S170 2008-06-23 30-day Notice
S169 2008-06-18 30-day Notice
S168 2008-06-03 30-day Notice
S167 2008-04-30 Real-time Process
S166 2008-04-21 30-day Notice
S165 2008-04-16 30-day Notice
S164 2008-03-12 Real-time Process
S163 2008-03-03 30-day Notice
S162 2008-02-25 30-day Notice
S161 2008-02-22 30-day Notice
S160 2008-01-17 Special (immediate Track)
S159 2008-01-07 30-day Notice
S158 2007-12-26 30-day Notice
S157 2007-12-21 30-day Notice
S156 2007-12-11 Real-time Process
S155 2007-12-07 Normal 180 Day Track
S154 2007-11-09 30-day Notice
S153 2007-10-17 30-day Notice
S152 2007-10-09 30-day Notice
S151 2007-10-09 30-day Notice
S150 2007-09-05 Real-time Process
S149 2007-08-31 30-day Notice
S148 2007-08-23 Normal 180 Day Track
S147 2007-08-23 Normal 180 Day Track
S146 2007-07-23 Real-time Process
S145 2007-05-23 30-day Notice
S144 2007-03-13 Special (immediate Track)
S143 2007-02-12 135 Review Track For 30-day Notice
S142 2007-01-17 30-day Notice
S141 2007-01-16 Real-time Process
S140 2007-01-16 30-day Notice
S139 2006-12-01 30-day Notice
S138 2006-11-30 135 Review Track For 30-day Notice
S137 2006-11-28 30-day Notice
S136 2006-11-06 30-day Notice
S135 2006-11-01 Real-time Process
S134
S133
S132
S131
S130 2006-06-26 30-day Notice
S129 2006-06-20 30-day Notice
S128 2006-05-23 Special (immediate Track)
S127 2006-05-12 Normal 180 Day Track
S126 2006-05-05 Normal 180 Day Track
S125 2006-05-02 135 Review Track For 30-day Notice
S124
S123
S122 2006-04-13 30-day Notice
S121 2006-04-13 30-day Notice
S120 2006-03-31 30-day Notice
S119 2006-03-28 30-day Notice
S118 2006-03-27 135 Review Track For 30-day Notice
S117 2006-03-27 30-day Notice
S116 2006-03-23 30-day Notice
S115 2006-03-06 Real-time Process
S114 2006-03-06 Special (immediate Track)
S113 2006-03-03 30-day Notice
S112 2006-03-03 30-day Notice
S111 2006-03-03 30-day Notice
S110 2006-03-03 135 Review Track For 30-day Notice
S109 2006-03-02 30-day Notice
S108 2006-02-06 135 Review Track For 30-day Notice
S107 2005-12-21 30-day Notice
S106 2005-12-21 135 Review Track For 30-day Notice
S105 2005-12-21 30-day Notice
S104 2005-12-21 135 Review Track For 30-day Notice
S103 2005-12-21 30-day Notice
S102 2005-12-21 30-day Notice
S101
S100 2006-01-28 Real-time Process
S099 2005-12-21 30-day Notice
S098 2005-12-21 30-day Notice
S097 2005-12-21 30-day Notice
S096 2005-12-21 30-day Notice
S095
S094 2005-12-16 30-day Notice
S093
S092
S091 2005-11-22 135 Review Track For 30-day Notice
S090 2005-11-17 30-day Notice
S089 2005-11-16 30-day Notice
S088 2005-10-11 135 Review Track For 30-day Notice
S087 2005-10-03 135 Review Track For 30-day Notice
S086 2005-09-26 Real-time Process
S085 2005-08-25 30-day Notice
S084 2005-08-25 Real-time Process
S083 2005-08-25 Real-time Process
S082 2005-08-24 30-day Notice
S081
S080 2005-08-19 30-day Notice
S079 2005-08-16 30-day Notice
S078 2005-08-16 Special (immediate Track)
S077 2005-08-15 30-day Notice
S076 2005-08-15 30-day Notice
S075 2005-08-15 135 Review Track For 30-day Notice
S074 2005-08-15 30-day Notice
S073 2005-08-12 30-day Notice
S072 2005-08-11 Real-time Process
S071
S070 2005-08-09 30-day Notice
S069 2005-08-04 30-day Notice
S068
S067 2005-07-12 Real-time Process
S066 2005-07-06 Real-time Process
S065
S064 2005-06-27 30-day Notice
S063 2005-06-27 30-day Notice
S062 2005-06-24 30-day Notice
S061 2005-06-23 30-day Notice
S060
S059 2005-06-21 30-day Notice
S058 2005-06-21 30-day Notice
S057
S056 2005-06-15 30-day Notice
S055 2005-05-26 30-day Notice
S054 2005-05-12 Real-time Process
S053 2005-03-25 Real-time Process
S052 2005-03-18 Real-time Process
S051 2004-12-10 Real-time Process
S050 2004-12-03 30-day Notice
S049 2004-11-26 Real-time Process
S048 2004-10-21 30-day Notice
S047 2004-10-05 Real-time Process
S046 2004-10-05 Real-time Process
S045 2004-07-21 30-day Notice
S044 2004-04-14 30-day Notice
S043 2004-04-08 Real-time Process
S042 2004-01-21 Real-time Process
S041 2004-01-16 Real-time Process
S040 2004-01-13 30-day Notice
S039 2003-12-22 Real-time Process
S038 2003-11-26 Special (immediate Track)
S037 2003-11-20 30-day Notice
S036 2003-11-12 Normal 180 Day Track
S035 2003-09-11 Real-time Process
S034 2003-07-16 Normal 180 Day Track
S033 2003-05-22 Real-time Process
S032 2003-04-01 Normal 180 Day Track
S031 2003-03-17 Normal 180 Day Track
S030 2002-12-12 Normal 180 Day Track
S029 2002-09-03 Normal 180 Day Track
S028 2002-08-05 Panel Track
S027 2002-08-01 Normal 180 Day Track
S026 2001-12-14 Panel Track
S025 2001-11-14 Normal 180 Day Track
S024 2001-10-05 Real-time Process
S023 2001-06-06 Normal 180 Day Track
S022 2001-05-23 Real-time Process
S021 2001-02-26 Real-time Process
S020 2000-12-26 Real-time Process
S019 2000-12-01 Real-time Process
S018
S017 2000-07-25 Normal 180 Day Track
S016 2000-06-29 Real-time Process
S015 2000-06-08 Real-time Process
S014 2000-06-05 Real-time Process
S013 1999-12-20 Normal 180 Day Track
S012 1999-08-23 Normal 180 Day Track
S011
S010 1999-01-13 Normal 180 Day Track
S009 1999-01-12 Normal 180 Day Track
S008 1998-12-03 Normal 180 Day Track
S007 1998-11-25 Normal 180 Day Track
S006 1998-04-22 Normal 180 Day Track
S005 1998-01-22 Special (immediate Track)
S004 1997-12-02 Normal 180 Day Track
S003 1997-11-04 Normal 180 Day Track
S002 1997-09-30 Normal 180 Day Track
S001 1997-07-18 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00802526480720 P960040 235
00802526480775 P960040 235
00802526480676 P960040 235
00802526480683 P960040 235
00802526480690 P960040 235
00802526480706 P960040 235
00802526480713 P960040 235
00802526480782 P960040 235
00802526480768 P960040 235
00802526480751 P960040 235
00802526480744 P960040 235
00802526480737 P960040 235
00802526480676 P960040 235
00802526480775 P960040 235
00802526480768 P960040 235
00802526480751 P960040 235
00802526480744 P960040 235
00802526480737 P960040 235
00802526480782 P960040 235
00802526480720 P960040 235
00802526480713 P960040 235
00802526480706 P960040 235
00802526480690 P960040 235
00802526480683 P960040 235
00802526533921 P960040 306
00802526533907 P960040 306
00802526534829 P960040 306
00802526534324 P960040 306
00802526534300 P960040 306
00802526533808 P960040 306
00802526533822 P960040 306
00802526533846 P960040 306
00802526533860 P960040 306
00802526533884 P960040 306
00802526534829 P960040 306
00802526534201 P960040 306
00802526534225 P960040 306
00802526534249 P960040 306
00802526534263 P960040 306
00802526534287 P960040 306
00802526533785 P960040 306
00802526534324 P960040 306
00802526533921 P960040 306
00802526534287 P960040 306
00802526534263 P960040 306
00802526533822 P960040 306
00802526533846 P960040 306
00802526533860 P960040 306
00802526533884 P960040 306
00802526534249 P960040 306
00802526533808 P960040 306
00802526533785 P960040 306
00802526533907 P960040 306
00802526534225 P960040 306
00802526534201 P960040 306
00802526534300 P960040 306
00802526588044 P960040 385
00802526587955 P960040 385
00802526587924 P960040 385
00802526587894 P960040 385
00802526587863 P960040 385
00802526587801 P960040 385
00802526587788 P960040 385
00802526587726 P960040 385
00802526587702 P960040 385
00802526588044 P960040 385
00802526587726 P960040 385
00802526587801 P960040 385
00802526587863 P960040 385
00802526587894 P960040 385
00802526587702 P960040 385
00802526587924 P960040 385
00802526588075 P960040 385
00802526587955 P960040 385
00802526588075 P960040 385
00802526587788 P960040 385
00802526533761 P960040 394
00802526533747 P960040 394
00802526533723 P960040 394
00802526535024 P960040 394
00802526533709 P960040 394
00802526534188 P960040 394
00802526534140 P960040 394
00802526534164 P960040 394
00802526534188 P960040 394
00802526534140 P960040 394
00802526534164 P960040 394
00802526535024 P960040 394
00802526533761 P960040 394
00802526533747 P960040 394
00802526533723 P960040 394
00802526533709 P960040 394

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