Ellipse ICD s

Implantable Cardioverter Defibrillator (non-crt)

FDA Premarket Approval P910023 S421

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 automate stacking hv capacitor components

DeviceEllipse ICD s
Classification NameImplantable Cardioverter Defibrillator (non-crt)
Generic NameImplantable Cardioverter Defibrillator (non-crt)
ApplicantSt. Jude Medical
Date Received2019-10-22
Decision Date2019-11-14
PMAP910023
SupplementS421
Product CodeLWS
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical 15900 Valley View Ct. sylmar, CA 91342-3577

Supplemental Filings

Supplement NumberDateSupplement Type
P910023Original Filing
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

NIH GUDID Devices

Device IDPMASupp
05414734500029 P910023 000
05414734500463 P910023 047
05414734500258 P910023 052
05414734500241 P910023 053
05414734502078 P910023 132
05414734501941 P910023 132
H75812073005 P910023 132
05414734501927 P910023 132
H75822073006 P910023 132
05414734502207 P910023 133
05414734502184 P910023 133
H75821073005 P910023 133
05414734504331 P910023 154
05414734503655 P910023 154
05414734507011 P910023 173
05414734503686 P910023 199
05414734503723 P910023 199
05414734503716 P910023 201
05414734503709 P910023 201
05414734502634 P910023 215
05414734503075 P910023 215
05414734503044 P910023 215
H758CD2215360 P910023 215
05414734504348 P910023 226
05414734504355 P910023 226
05414734504379 P910023 226
05414734504386 P910023 226
05414734505994 P910023 279
05414734505468 P910023 279
05414734505475 P910023 279
05414734507721 P910023 279
05414734507714 P910023 279
05414734508070 P910023 279
05414734507608 P910023 279
05414734507592 P910023 279
05414734506113 P910023 279
05414734506106 P910023 279
05414734506038 P910023 279
05414734505543 P910023 279
05414734505550 P910023 279
05414734505901 P910023 279
05414734505918 P910023 279
05414734505987 P910023 279
05414734506021 P910023 279
05414734508063 P910023 309
05414734508087 P910023 309
05414734507974 P910023 309
05414734507967 P910023 309
05414734507950 P910023 309
05414734507943 P910023 309
05414734507738 P910023 309
05414734507707 P910023 309
05414734507615 P910023 309
05414734507585 P910023 309
05414734508094 P910023 309

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