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.
Chip modifications and a yield improvement at the chip supplier.
Device | ICDS/CRT-DS |
Classification Name | Pulse Generator, Permanent, Implantable |
Generic Name | Pulse Generator, Permanent, Implantable |
Applicant | St. Jude Medical |
Date Received | 2006-05-09 |
Decision Date | 2006-06-08 |
PMA | P910023 |
Supplement | S108 |
Product Code | NVZ |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | St. Jude Medical 15900 Valley View Ct. sylmar, CA 91342-3577 |
Supplement Number | Date | Supplement Type |
---|---|---|
P910023 | Original Filing | |
S448 | 2022-08-24 | 30-day Notice |
S447 | ||
S446 | 2022-07-01 | 30-day Notice |
S445 | 2022-05-27 | 30-day Notice |
S444 | 2022-04-21 | 30-day Notice |
S443 | 2022-03-07 | Real-time Process |
S442 | 2021-10-18 | Real-time Process |
S441 | 2021-10-18 | Real-time Process |
S440 | 2021-08-04 | 30-day Notice |
S439 | ||
S438 | 2021-06-28 | 30-day Notice |
S437 | 2021-04-02 | Real-time Process |
S436 | 2021-03-12 | 30-day Notice |
S435 | ||
S434 | 2020-11-25 | 30-day Notice |
S433 | 2020-10-21 | 30-day Notice |
S432 | 2020-08-31 | 30-day Notice |
S431 | 2020-07-17 | 30-day Notice |
S430 | ||
S429 | ||
S428 | ||
S427 | 2020-04-24 | 30-day Notice |
S426 | 2020-02-18 | 30-day Notice |
S425 | 2020-02-13 | 30-day Notice |
S424 | 2019-12-09 | 30-day Notice |
S423 | ||
S422 | 2019-10-30 | Real-time Process |
S421 | 2019-10-22 | 30-day Notice |
S420 | 2019-09-26 | 30-day Notice |
S419 | 2019-09-23 | 30-day Notice |
S418 | 2019-08-07 | 30-day Notice |
S417 | 2019-07-24 | 30-day Notice |
S416 | 2019-03-01 | Real-time Process |
S415 | 2018-11-20 | 30-day Notice |
S414 | 2018-10-29 | Real-time Process |
S413 | 2018-10-09 | 30-day Notice |
S412 | 2018-09-28 | 30-day Notice |
S411 | 2018-07-17 | 30-day Notice |
S410 | 2018-06-20 | Normal 180 Day Track |
S409 | 2018-05-21 | 30-day Notice |
S408 | 2018-04-05 | 30-day Notice |
S407 | 2018-03-14 | 30-day Notice |
S406 | 2018-03-12 | 30-day Notice |
S405 | 2018-02-09 | 30-day Notice |
S404 | 2018-02-07 | 30-day Notice |
S403 | 2018-01-31 | 30-day Notice |
S402 | 2018-01-29 | 30-day Notice |
S401 | 2018-01-18 | 30-day Notice |
S400 | 2018-01-18 | Normal 180 Day Track |
S399 | 2017-12-21 | 30-day Notice |
S398 | 2017-11-13 | 30-day Notice |
S397 | 2017-11-13 | 30-day Notice |
S396 | 2017-10-30 | Real-time Process |
S395 | 2017-10-10 | 30-day Notice |
S394 | 2017-09-22 | 30-day Notice |
S393 | 2017-09-21 | 30-day Notice |
S392 | 2017-08-16 | 30-day Notice |
S391 | 2017-08-01 | 30-day Notice |
S390 | 2017-07-31 | Real-time Process |
S389 | 2017-07-31 | Real-time Process |
S388 | 2017-07-03 | Normal 180 Day Track |
S387 | 2017-06-29 | 30-day Notice |
S386 | 2017-05-17 | Normal 180 Day Track |
S385 | 2017-04-06 | 30-day Notice |
S384 | 2017-04-03 | Normal 180 Day Track |
S383 | 2017-02-28 | 30-day Notice |
S382 | 2017-02-07 | Real-time Process |
S381 | 2017-02-01 | Real-time Process |
S380 | 2017-01-30 | 30-day Notice |
S379 | 2017-01-26 | 30-day Notice |
S378 | 2016-12-14 | Real-time Process |
S377 | 2016-11-30 | 30-day Notice |
S376 | 2016-10-21 | 30-day Notice |
S375 | 2016-07-05 | Real-time Process |
S374 | 2016-06-24 | 30-day Notice |
S373 | 2016-06-13 | Real-time Process |
S372 | 2016-04-26 | Real-time Process |
S371 | 2016-04-04 | Real-time Process |
S370 | 2016-02-03 | Real-time Process |
S369 | 2016-01-27 | 30-day Notice |
S368 | ||
S367 | 2016-01-12 | 30-day Notice |
S366 | 2015-11-25 | 30-day Notice |
S365 | 2015-10-26 | 135 Review Track For 30-day Notice |
S364 | 2015-09-29 | Real-time Process |
S363 | 2015-09-17 | 30-day Notice |
S362 | 2015-09-15 | Normal 180 Day Track |
S361 | 2015-08-17 | Normal 180 Day Track |
S360 | 2015-08-13 | 30-day Notice |
S359 | 2015-08-10 | 30-day Notice |
S358 | 2015-07-23 | Real-time Process |
S357 | 2015-05-19 | Real-time Process |
S356 | 2015-03-25 | 30-day Notice |
S355 | 2015-02-11 | Normal 180 Day Track |
S354 | 2015-02-04 | Real-time Process |
S353 | 2015-01-28 | 30-day Notice |
S352 | 2014-12-18 | Real-time Process |
S351 | 2014-12-08 | Real-time Process |
S350 | ||
S349 | 2014-11-17 | 30-day Notice |
S348 | 2014-11-03 | Real-time Process |
S347 | 2014-10-27 | 30-day Notice |
S346 | 2014-10-20 | Real-time Process |
S345 | 2014-09-26 | 30-day Notice |
S344 | 2014-09-15 | Real-time Process |
S343 | 2014-08-22 | Real-time Process |
S342 | 2014-07-02 | Normal 180 Day Track |
S341 | 2014-06-30 | 30-day Notice |
S340 | 2014-06-16 | 30-day Notice |
S339 | 2014-06-10 | Real-time Process |
S338 | 2014-05-30 | 30-day Notice |
S337 | 2014-05-28 | 30-day Notice |
S336 | 2014-05-22 | Real-time Process |
S335 | 2014-04-30 | 30-day Notice |
S334 | 2014-04-21 | 30-day Notice |
S333 | 2014-04-15 | Real-time Process |
S332 | 2014-02-18 | 30-day Notice |
S331 | 2014-02-28 | Real-time Process |
S330 | 2014-02-05 | 30-day Notice |
S329 | 2014-02-05 | 30-day Notice |
S328 | 2014-01-24 | Real-time Process |
S327 | 2014-01-23 | 30-day Notice |
S326 | ||
S325 | 2014-01-13 | 30-day Notice |
S324 | 2013-11-29 | 30-day Notice |
S323 | 2013-11-21 | Normal 180 Day Track |
S322 | 2013-10-28 | 30-day Notice |
S321 | 2013-09-25 | Real-time Process |
S320 | 2013-07-31 | 30-day Notice |
S319 | 2013-05-13 | 30-day Notice |
S318 | 2013-05-13 | 30-day Notice |
S317 | ||
S316 | 2013-05-13 | 30-day Notice |
S315 | 2013-05-09 | 30-day Notice |
S314 | 2013-04-15 | 30-day Notice |
S313 | 2013-01-30 | 30-day Notice |
S312 | 2012-12-11 | 135 Review Track For 30-day Notice |
S311 | 2012-12-05 | Normal 180 Day Track |
S310 | 2012-11-21 | 30-day Notice |
S309 | 2012-11-14 | Normal 180 Day Track |
S308 | ||
S307 | 2012-10-15 | Normal 180 Day Track |
S306 | 2012-09-28 | 30-day Notice |
S305 | ||
S304 | 2012-09-13 | 30-day Notice |
S303 | 2012-08-27 | 30-day Notice |
S302 | 2012-08-16 | Real-time Process |
S301 | ||
S300 | 2012-08-07 | 30-day Notice |
S299 | 2012-07-27 | 30-day Notice |
S298 | 2012-07-19 | Normal 180 Day Track No User Fee |
S297 | 2012-07-11 | Normal 180 Day Track |
S296 | 2012-05-30 | Real-time Process |
S295 | 2012-05-25 | Normal 180 Day Track |
S294 | 2012-04-03 | 30-day Notice |
S293 | 2012-02-29 | Real-time Process |
S292 | ||
S291 | 2012-02-22 | Real-time Process |
S290 | 2012-02-13 | 135 Review Track For 30-day Notice |
S289 | 2012-02-13 | 30-day Notice |
S288 | 2012-02-10 | 30-day Notice |
S287 | 2012-02-09 | Real-time Process |
S286 | ||
S285 | 2011-12-22 | Normal 180 Day Track No User Fee |
S284 | ||
S283 | ||
S282 | 2011-12-05 | 30-day Notice |
S281 | 2011-11-30 | 135 Review Track For 30-day Notice |
S280 | 2011-11-04 | 30-day Notice |
S279 | 2011-11-01 | Normal 180 Day Track |
S278 | 2011-10-26 | 30-day Notice |
S277 | 2011-10-25 | 30-day Notice |
S276 | 2011-09-12 | Real-time Process |
S275 | 2011-09-13 | 30-day Notice |
S274 | 2011-09-09 | 30-day Notice |
S273 | 2011-08-31 | Real-time Process |
S272 | 2011-08-08 | Real-time Process |
S271 | 2011-07-26 | Real-time Process |
S270 | 2011-07-19 | Normal 180 Day Track |
S269 | 2011-07-18 | 30-day Notice |
S268 | 2011-07-15 | 30-day Notice |
S267 | 2011-06-28 | Real-time Process |
S266 | 2011-05-18 | Normal 180 Day Track No User Fee |
S265 | 2011-05-11 | 135 Review Track For 30-day Notice |
S264 | 2011-05-02 | Normal 180 Day Track |
S263 | 2011-04-19 | Normal 180 Day Track |
S262 | 2011-04-11 | 30-day Notice |
S261 | 2011-04-05 | 30-day Notice |
S260 | 2011-04-05 | 30-day Notice |
S259 | ||
S258 | 2011-03-22 | 135 Review Track For 30-day Notice |
S257 | 2011-03-14 | Normal 180 Day Track |
S256 | 2011-03-09 | 135 Review Track For 30-day Notice |
S255 | 2010-12-03 | 30-day Notice |
S254 | 2010-11-23 | Normal 180 Day Track |
S253 | 2010-11-22 | 135 Review Track For 30-day Notice |
S252 | 2010-11-15 | 30-day Notice |
S251 | 2010-09-29 | 30-day Notice |
S250 | 2010-09-20 | 30-day Notice |
S249 | 2010-08-19 | Real-time Process |
S248 | 2010-07-30 | Real-time Process |
S247 | 2010-07-29 | 30-day Notice |
S246 | 2010-07-26 | Real-time Process |
S245 | 2010-07-19 | 30-day Notice |
S244 | 2010-07-19 | 30-day Notice |
S243 | 2010-07-13 | Normal 180 Day Track No User Fee |
S242 | 2010-07-07 | 30-day Notice |
S241 | 2010-07-06 | 30-day Notice |
S240 | 2010-07-06 | Real-time Process |
S239 | 2010-07-22 | Real-time Process |
S238 | 2010-06-24 | Special (immediate Track) |
S237 | 2010-06-17 | 30-day Notice |
S236 | 2010-06-04 | Normal 180 Day Track |
S235 | 2010-05-21 | 30-day Notice |
S234 | 2010-05-21 | 30-day Notice |
S233 | 2010-05-19 | Real-time Process |
S232 | 2010-04-30 | Real-time Process |
S231 | 2010-03-26 | 30-day Notice |
S230 | 2010-02-04 | 30-day Notice |
S229 | 2010-01-25 | 135 Review Track For 30-day Notice |
S228 | 2009-12-24 | 30-day Notice |
S227 | 2009-11-25 | Normal 180 Day Track No User Fee |
S226 | 2009-11-05 | Normal 180 Day Track |
S225 | 2009-10-29 | 30-day Notice |
S224 | 2009-10-27 | Real-time Process |
S223 | 2009-10-22 | Real-time Process |
S222 | 2009-10-19 | 30-day Notice |
S221 | 2009-10-02 | 135 Review Track For 30-day Notice |
S220 | 2009-09-16 | Real-time Process |
S219 | 2009-09-14 | Real-time Process |
S218 | 2009-09-14 | 30-day Notice |
S217 | 2009-09-02 | 30-day Notice |
S216 | 2009-09-01 | Real-time Process |
S215 | 2009-08-04 | Normal 180 Day Track |
S214 | 2009-06-23 | 30-day Notice |
S213 | 2009-06-18 | 30-day Notice |
S212 | 2009-06-10 | 30-day Notice |
S211 | 2009-05-21 | 30-day Notice |
S210 | 2009-05-11 | 30-day Notice |
S209 | ||
S208 | 2009-04-08 | Real-time Process |
S207 | 2009-04-08 | Real-time Process |
S206 | 2009-04-02 | Real-time Process |
S205 | 2009-03-30 | 30-day Notice |
S204 | 2009-03-23 | Real-time Process |
S203 | 2009-03-04 | Real-time Process |
S202 | 2009-02-17 | Real-time Process |
S201 | 2009-02-10 | Real-time Process |
S200 | 2009-01-21 | Normal 180 Day Track No User Fee |
S199 | 2009-01-02 | Real-time Process |
S198 | 2008-12-31 | Real-time Process |
S197 | 2008-11-28 | Real-time Process |
S196 | 2008-11-26 | Real-time Process |
S195 | 2008-11-24 | Real-time Process |
S194 | 2008-11-13 | Real-time Process |
S193 | 2008-11-07 | 30-day Notice |
S192 | 2008-10-23 | 30-day Notice |
S191 | 2008-10-22 | Real-time Process |
S190 | 2008-10-15 | Real-time Process |
S189 | 2008-09-04 | Normal 180 Day Track No User Fee |
S188 | 2008-08-19 | Real-time Process |
S187 | 2008-08-11 | 30-day Notice |
S186 | 2008-08-11 | 30-day Notice |
S185 | 2008-08-11 | Special (immediate Track) |
S184 | 2008-07-30 | Real-time Process |
S183 | 2008-07-24 | 135 Review Track For 30-day Notice |
S182 | 2008-06-17 | Real-time Process |
S181 | 2008-06-13 | 30-day Notice |
S180 | 2008-06-02 | Real-time Process |
S179 | 2008-05-30 | Real-time Process |
S178 | 2008-05-28 | Real-time Process |
S177 | 2008-05-22 | 30-day Notice |
S176 | 2008-05-21 | 30-day Notice |
S175 | 2008-05-09 | Real-time Process |
S174 | 2008-04-15 | 30-day Notice |
S173 | 2008-04-10 | Real-time Process |
S172 | 2008-03-25 | Real-time Process |
S171 | 2008-03-25 | Real-time Process |
S170 | 2008-03-19 | Real-time Process |
S169 | 2008-02-12 | Special (immediate Track) |
S168 | 2008-02-06 | Real-time Process |
S167 | 2008-02-04 | 30-day Notice |
S166 | 2007-12-26 | 30-day Notice |
S165 | 2007-12-20 | 30-day Notice |
S164 | 2007-12-13 | 30-day Notice |
S163 | 2007-12-06 | 30-day Notice |
S162 | 2007-10-24 | Real-time Process |
S161 | 2007-10-22 | Real-time Process |
S160 | 2007-10-22 | Real-time Process |
S159 | 2007-10-19 | Normal 180 Day Track No User Fee |
S158 | 2007-09-24 | 30-day Notice |
S157 | 2007-09-21 | Real-time Process |
S156 | 2007-09-20 | 30-day Notice |
S155 | 2007-09-13 | 30-day Notice |
S154 | 2007-09-05 | Normal 180 Day Track |
S153 | 2007-08-30 | 30-day Notice |
S152 | 2007-08-23 | 30-day Notice |
S151 | 2007-08-13 | Real-time Process |
S150 | 2007-08-13 | Normal 180 Day Track |
S149 | ||
S148 | ||
S147 | ||
S146 | 2007-07-19 | 30-day Notice |
S145 | 2007-07-19 | 30-day Notice |
S144 | 2007-07-19 | 30-day Notice |
S143 | 2007-06-25 | 30-day Notice |
S142 | 2007-05-21 | Real-time Process |
S141 | 2007-05-07 | 30-day Notice |
S140 | 2007-05-02 | 30-day Notice |
S139 | 2007-04-25 | 30-day Notice |
S138 | 2007-04-23 | Normal 180 Day Track |
S137 | 2007-04-17 | 30-day Notice |
S136 | 2007-04-16 | 135 Review Track For 30-day Notice |
S135 | 2007-04-16 | 30-day Notice |
S134 | 2007-04-13 | Real-time Process |
S133 | 2007-04-06 | Real-time Process |
S132 | 2007-04-06 | Normal 180 Day Track |
S131 | 2007-02-21 | Real-time Process |
S130 | 2006-12-21 | 30-day Notice |
S129 | 2006-12-13 | 30-day Notice |
S128 | 2006-11-30 | Real-time Process |
S127 | 2006-11-30 | Real-time Process |
S126 | 2006-11-21 | Real-time Process |
S125 | 2006-10-25 | 30-day Notice |
S124 | 2006-10-20 | Real-time Process |
S123 | 2006-10-18 | 30-day Notice |
S122 | 2006-10-12 | Real-time Process |
S121 | 2006-10-06 | Real-time Process |
S120 | 2006-09-27 | 30-day Notice |
S119 | ||
S118 | 2006-09-07 | 30-day Notice |
S117 | 2006-09-07 | 30-day Notice |
S116 | 2006-08-28 | 30-day Notice |
S115 | 2006-08-04 | Real-time Process |
S114 | 2006-07-13 | 30-day Notice |
S113 | 2006-07-03 | 30-day Notice |
S112 | 2006-06-26 | Real-time Process |
S111 | 2006-06-07 | Real-time Process |
S110 | 2006-05-30 | 30-day Notice |
S109 | 2006-05-09 | Real-time Process |
S108 | 2006-05-09 | 30-day Notice |
S107 | 2006-04-26 | 30-day Notice |
S106 | ||
S105 | ||
S104 | 2006-03-30 | Real-time Process |
S103 | 2006-03-07 | Real-time Process |
S102 | 2006-02-17 | Normal 180 Day Track |
S101 | 2006-02-15 | 30-day Notice |
S100 | 2006-02-03 | Real-time Process |
S099 | 2006-02-07 | 135 Review Track For 30-day Notice |
S098 | 2006-02-02 | Real-time Process |
S097 | 2006-01-31 | 30-day Notice |
S096 | ||
S095 | 2006-01-19 | 30-day Notice |
S094 | 2006-01-17 | 30-day Notice |
S093 | 2006-01-17 | 135 Review Track For 30-day Notice |
S092 | 2006-01-06 | Real-time Process |
S091 | 2005-12-23 | 30-day Notice |
S090 | 2005-12-05 | Real-time Process |
S089 | 2005-11-14 | Normal 180 Day Track No User Fee |
S088 | 2005-11-09 | Normal 180 Day Track |
S087 | 2005-11-03 | 30-day Notice |
S086 | 2005-10-26 | 135 Review Track For 30-day Notice |
S085 | 2005-10-11 | Real-time Process |
S084 | 2005-10-03 | 30-day Notice |
S083 | 2005-09-19 | 30-day Notice |
S082 | ||
S081 | 2005-08-08 | Normal 180 Day Track |
S080 | 2005-07-29 | Real-time Process |
S079 | 2005-04-22 | 30-day Notice |
S078 | 2005-04-14 | Real-time Process |
S077 | 2005-04-12 | Real-time Process |
S076 | 2005-01-25 | Real-time Process |
S075 | 2004-09-08 | Normal 180 Day Track |
S074 | ||
S073 | 2004-04-15 | Real-time Process |
S072 | 2004-03-22 | Real-time Process |
S071 | 2003-10-07 | Real-time Process |
S070 | ||
S069 | 2003-09-11 | Real-time Process |
S068 | 2003-08-05 | Real-time Process |
S067 | 2003-04-14 | Real-time Process |
S066 | 2003-03-03 | Real-time Process |
S065 | 2003-02-07 | Normal 180 Day Track |
S064 | 2003-01-17 | 30-day Notice |
S063 | 2002-12-24 | Real-time Process |
S062 | 2002-08-02 | Real-time Process |
S061 | 2002-07-17 | Real-time Process |
S060 | 2002-02-27 | Special (immediate Track) |
S059 | ||
S058 | 2001-11-29 | Real-time Process |
S057 | 2001-10-29 | Real-time Process |
S056 | 2001-09-17 | Real-time Process |
S055 | 2001-09-05 | Real-time Process |
S054 | 2001-08-10 | Real-time Process |
S053 | 2001-06-28 | Real-time Process |
S052 | 2001-05-09 | Real-time Process |
S051 | 2001-02-09 | Real-time Process |
S050 | 2000-12-19 | 30-day Notice |
S049 | 2000-11-02 | Real-time Process |
S048 | 2000-08-11 | Normal 180 Day Track |
S047 | 2000-06-14 | Panel Track |
S046 | ||
S045 | 1999-08-30 | Real-time Process |
S044 | 1999-08-23 | Normal 180 Day Track |
S043 | 1999-04-26 | Normal 180 Day Track |
S042 | 1999-03-31 | Real-time Process |
S041 | 1999-03-31 | Real-time Process |
S040 | 1999-02-08 | Normal 180 Day Track |
S039 | 1999-02-08 | Special (immediate Track) |
S038 | 1999-02-04 | Normal 180 Day Track |
S037 | 1998-11-23 | Real-time Process |
S036 | 1998-08-24 | Normal 180 Day Track |
S035 | 1998-08-27 | Real-time Process |
S034 | 1998-07-31 | Normal 180 Day Track |
S033 | 1998-05-22 | Normal 180 Day Track |
S032 | 1997-12-29 | Normal 180 Day Track |
S031 | 1997-09-12 | Normal 180 Day Track |
S030 | 1997-09-08 | Normal 180 Day Track |
S029 | 1997-06-23 | Normal 180 Day Track |
S028 | 1997-04-09 | Normal 180 Day Track |
S027 | 1997-05-07 | Normal 180 Day Track |
S026 | 1997-05-02 | Normal 180 Day Track |
S025 | 1997-01-15 | Normal 180 Day Track |
S024 | 1996-11-25 | Normal 180 Day Track |
S023 | 1996-10-04 | Normal 180 Day Track |
S022 | 1996-08-02 | Normal 180 Day Track |
S021 | ||
S020 | 1996-06-14 | Normal 180 Day Track |
S019 | 1996-04-19 | Normal 180 Day Track |
S018 | 1996-04-08 | Normal 180 Day Track |
S017 | 1996-03-28 | Normal 180 Day Track |
S016 | 1996-03-26 | Normal 180 Day Track |
S015 | 1996-03-21 | Normal 180 Day Track |
S014 | 1995-11-13 | Normal 180 Day Track |
S013 | 1995-07-31 | Normal 180 Day Track |
S012 | 1995-06-30 | Normal 180 Day Track |
S011 | 1995-05-15 | Normal 180 Day Track |
S010 | 1995-03-31 | Special (immediate Track) |
S009 | 1994-10-12 | Normal 180 Day Track |
S008 | 1994-08-26 | Normal 180 Day Track |
S007 | 1994-08-16 | Normal 180 Day Track |
S006 | 1994-08-15 | Panel Track |
S005 | 1994-03-10 | Normal 180 Day Track |
S004 | 1993-10-18 | Normal 180 Day Track |
S003 | 1993-10-01 | Normal 180 Day Track |
S002 | 1993-09-09 | Normal 180 Day Track |
S001 | 1993-05-20 | Normal 180 Day Track |