Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet

FDA Premarket Approval P030054 S376

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 adopt sterilization recipe cycle pg 600 for the abbott penang malaysia manufacturing facility

DeviceUnify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet
Generic NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
ApplicantSt. Jude Medical
Date Received2020-02-13
Decision Date2020-02-28
PMAP030054
SupplementS376
Product CodeNIK 
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
P030054Original Filing
S377 2020-02-27 30-day Notice
S376 2020-02-13 30-day Notice
S375 2019-12-09 30-day Notice
S374
S373 2019-10-30 Real-time Process
S372 2019-10-09 Normal 180 Day Track No User Fee
S371 2019-09-23 30-day Notice
S370 2019-08-07 30-day Notice
S369 2019-07-24 30-day Notice
S368
S367 2018-11-30 30-day Notice
S366 2018-11-23 30-day Notice
S365 2018-11-20 30-day Notice
S364 2018-10-29 Real-time Process
S363 2018-10-09 30-day Notice
S362 2018-10-02 30-day Notice
S361 2018-10-01 30-day Notice
S360 2018-09-28 30-day Notice
S359 2018-07-25 Normal 180 Day Track No User Fee
S358 2018-07-17 30-day Notice
S357 2018-07-02 30-day Notice
S356 2018-06-28 Normal 180 Day Track
S355 2018-06-20 Normal 180 Day Track
S354 2018-05-21 30-day Notice
S353 2018-04-05 30-day Notice
S352 2018-03-14 30-day Notice
S351 2018-03-12 30-day Notice
S350 2018-03-05 30-day Notice
S349 2018-02-27 30-day Notice
S348 2018-01-31 30-day Notice
S347 2018-01-29 30-day Notice
S346 2018-01-26 30-day Notice
S345 2018-01-18 30-day Notice
S344 2018-01-18 Normal 180 Day Track
S343 2017-12-21 30-day Notice
S342 2017-11-13 30-day Notice
S341 2017-11-13 30-day Notice
S340 2017-10-30 Real-time Process
S339 2017-10-10 30-day Notice
S338 2017-09-22 30-day Notice
S337 2017-09-21 30-day Notice
S336 2017-08-16 30-day Notice
S335 2017-08-01 30-day Notice
S334 2017-07-31 Real-time Process
S333 2017-07-31 Real-time Process
S332 2017-07-03 Normal 180 Day Track
S331 2017-06-29 30-day Notice
S330 2017-06-27 30-day Notice
S329 2017-05-17 Normal 180 Day Track
S328 2017-04-06 30-day Notice
S327 2017-04-03 Real-time Process
S326 2017-04-03 Normal 180 Day Track
S325 2017-02-28 30-day Notice
S324 2017-02-24 30-day Notice
S323 2017-02-17 135 Review Track For 30-day Notice
S322 2017-02-10 30-day Notice
S321 2017-02-07 Real-time Process
S320 2017-02-01 Real-time Process
S319 2017-01-30 30-day Notice
S318 2017-01-26 30-day Notice
S317 2017-01-25 30-day Notice
S316 2016-12-14 Real-time Process
S315 2016-12-13 30-day Notice
S314 2016-11-14 Normal 180 Day Track
S313 2016-10-21 30-day Notice
S312 2016-10-12 30-day Notice
S311 2016-09-27 135 Review Track For 30-day Notice
S310 2016-09-13 135 Review Track For 30-day Notice
S309
S308 2016-07-05 30-day Notice
S307 2016-07-05 Real-time Process
S306 2016-06-24 30-day Notice
S305 2016-06-22 30-day Notice
S304 2016-04-26 Real-time Process
S303 2016-04-12 30-day Notice
S302 2016-04-04 Real-time Process
S301 2016-02-03 Real-time Process
S300
S299 2016-01-21 30-day Notice
S298 2016-01-19 30-day Notice
S297 2016-01-12 30-day Notice
S296 2015-11-25 30-day Notice
S295 2015-10-26 135 Review Track For 30-day Notice
S294 2015-09-29 Real-time Process
S293 2015-09-17 30-day Notice
S292 2015-09-15 Normal 180 Day Track
S291 2015-08-17 Normal 180 Day Track
S290 2015-08-17 Real-time Process
S289 2015-08-13 30-day Notice
S288 2015-08-10 30-day Notice
S287 2015-07-23 Real-time Process
S286 2015-05-19 Real-time Process
S285 2015-03-25 30-day Notice
S284 2015-02-11 Normal 180 Day Track
S283 2015-02-04 Real-time Process
S282 2015-01-28 30-day Notice
S281 2014-12-18 Real-time Process
S280 2014-12-08 Real-time Process
S279 2014-11-17 30-day Notice
S278 2014-11-03 Real-time Process
S277 2014-10-27 30-day Notice
S276 2014-10-20 Real-time Process
S275 2014-09-26 30-day Notice
S274 2014-08-22 Real-time Process
S273 2014-07-02 Normal 180 Day Track
S272 2014-06-30 30-day Notice
S271 2014-06-16 30-day Notice
S270 2014-05-30 30-day Notice
S269 2014-05-28 30-day Notice
S268 2014-05-22 Real-time Process
S267 2014-04-30 30-day Notice
S266 2014-04-21 30-day Notice
S265 2014-04-15 Real-time Process
S264
S263 2014-02-18 30-day Notice
S262 2014-02-28 Real-time Process
S261 2014-02-05 30-day Notice
S260 2014-02-05 30-day Notice
S259 2014-01-24 Real-time Process
S258 2014-01-23 30-day Notice
S257
S256 2014-01-13 30-day Notice
S255 2013-11-29 30-day Notice
S254 2013-11-21 Normal 180 Day Track
S253 2013-10-28 30-day Notice
S252 2013-07-31 30-day Notice
S251 2013-05-13 30-day Notice
S250 2013-05-13 30-day Notice
S249
S248 2013-05-13 30-day Notice
S247
S246 2013-06-03 Real-time Process
S245 2013-04-15 30-day Notice
S244 2013-03-14 30-day Notice
S243 2013-01-30 30-day Notice
S242 2012-12-11 135 Review Track For 30-day Notice
S241 2012-12-05 Normal 180 Day Track
S240
S239 2012-11-21 30-day Notice
S238 2012-11-14 Normal 180 Day Track
S237 2012-10-15 Normal 180 Day Track
S236 2012-10-15 Normal 180 Day Track No User Fee
S235 2012-09-28 30-day Notice
S234
S233 2012-09-13 30-day Notice
S232 2012-09-05 Real-time Process
S231 2012-08-27 30-day Notice
S230 2012-08-16 Real-time Process
S229
S228 2012-08-07 30-day Notice
S227 2012-07-19 Normal 180 Day Track No User Fee
S226 2012-07-11 Normal 180 Day Track
S225 2012-07-10 30-day Notice
S224 2012-05-30 Real-time Process
S223 2012-05-25 Normal 180 Day Track
S222 2012-05-22 30-day Notice
S221 2012-04-03 30-day Notice
S220 2012-02-29 Real-time Process
S219
S218 2012-02-22 Real-time Process
S217 2012-02-13 135 Review Track For 30-day Notice
S216 2012-02-13 30-day Notice
S215 2012-02-10 30-day Notice
S214 2012-01-04 Normal 180 Day Track No User Fee
S213
S212 2011-12-23 Normal 180 Day Track No User Fee
S211
S210
S209 2011-12-05 30-day Notice
S208 2011-11-30 135 Review Track For 30-day Notice
S207 2011-11-04 30-day Notice
S206 2011-11-01 Normal 180 Day Track
S205 2011-10-26 30-day Notice
S204 2011-10-25 30-day Notice
S203 2011-09-13 30-day Notice
S202 2011-09-12 Real-time Process
S201 2011-09-09 30-day Notice
S200 2011-09-02 Real-time Process
S199 2011-08-31 Real-time Process
S198 2011-08-08 Real-time Process
S197 2011-07-26 Real-time Process
S196 2011-07-19 Normal 180 Day Track
S195 2011-07-18 30-day Notice
S194 2011-07-15 30-day Notice
S193 2011-06-28 Real-time Process
S192 2011-06-20 Real-time Process
S191 2011-05-18 Normal 180 Day Track No User Fee
S190 2011-05-11 135 Review Track For 30-day Notice
S189 2011-05-02 Normal 180 Day Track
S188 2011-04-19 Normal 180 Day Track
S187 2011-04-11 30-day Notice
S186 2011-04-05 30-day Notice
S185 2011-04-05 30-day Notice
S184
S183 2011-03-22 135 Review Track For 30-day Notice
S182 2011-03-18 Real-time Process
S181 2011-03-14 Normal 180 Day Track
S180 2011-03-09 135 Review Track For 30-day Notice
S179 2010-12-09 30-day Notice
S178 2010-12-03 30-day Notice
S177 2010-11-23 Normal 180 Day Track
S176 2010-11-22 135 Review Track For 30-day Notice
S175 2010-11-15 30-day Notice
S174 2010-11-12 30-day Notice
S173 2010-10-29 Normal 180 Day Track
S172 2010-09-29 30-day Notice
S171 2010-09-20 30-day Notice
S170 2010-08-20 Real-time Process
S169 2010-08-19 Real-time Process
S168 2010-08-16 Normal 180 Day Track No User Fee
S167 2010-07-30 Real-time Process
S166 2010-07-29 30-day Notice
S165 2010-07-26 Real-time Process
S164 2010-07-19 30-day Notice
S163 2010-07-19 30-day Notice
S162 2010-07-13 Normal 180 Day Track No User Fee
S161 2010-07-07 30-day Notice
S160 2010-07-06 30-day Notice
S159 2010-07-06 Real-time Process
S158 2010-06-30 Real-time Process
S157 2010-07-22 Real-time Process
S156 2010-06-24 Special (immediate Track)
S155 2010-06-22 Real-time Process
S154 2010-06-17 30-day Notice
S153 2010-06-04 Normal 180 Day Track
S152 2010-05-21 30-day Notice
S151 2010-05-21 30-day Notice
S150 2010-05-20 Normal 180 Day Track
S149 2010-05-19 Real-time Process
S148 2010-04-30 Real-time Process
S147 2010-03-26 30-day Notice
S146 2010-02-05 Normal 180 Day Track
S145 2010-02-04 30-day Notice
S144 2010-01-25 135 Review Track For 30-day Notice
S143 2009-12-24 30-day Notice
S142 2009-11-25 Normal 180 Day Track No User Fee
S141 2009-11-05 Normal 180 Day Track
S140 2009-10-29 30-day Notice
S139 2009-10-22 Real-time Process
S138 2009-10-19 30-day Notice
S137 2009-10-02 135 Review Track For 30-day Notice
S136 2009-09-14 30-day Notice
S135 2009-09-14 Real-time Process
S134 2009-09-02 30-day Notice
S133 2009-09-01 Real-time Process
S132 2009-08-28 30-day Notice
S131 2009-08-04 Normal 180 Day Track
S130 2009-07-16 Normal 180 Day Track
S129 2009-06-23 30-day Notice
S128 2009-06-18 30-day Notice
S127 2009-06-10 30-day Notice
S126 2009-05-21 30-day Notice
S125 2009-05-11 30-day Notice
S124
S123 2009-04-08 Real-time Process
S122 2009-04-02 Real-time Process
S121 2009-03-30 30-day Notice
S120 2009-03-23 Real-time Process
S119 2009-03-04 Real-time Process
S118 2009-02-17 Real-time Process
S117 2009-02-10 Real-time Process
S116 2009-02-06 Normal 180 Day Track No User Fee
S115 2009-01-30 30-day Notice
S114 2009-01-21 Normal 180 Day Track No User Fee
S113 2009-01-02 Real-time Process
S112 2008-12-31 Real-time Process
S111 2008-11-28 Real-time Process
S110 2008-11-24 Real-time Process
S109 2008-11-13 Real-time Process
S108 2008-11-07 30-day Notice
S107 2008-10-22 Real-time Process
S106 2008-10-15 Real-time Process
S105 2008-09-11 30-day Notice
S104 2008-09-04 Normal 180 Day Track No User Fee
S103 2008-08-19 Real-time Process
S102 2008-08-11 30-day Notice
S101 2008-08-11 30-day Notice
S100 2008-08-11 Special (immediate Track)
S099 2008-07-30 Real-time Process
S098 2008-07-24 135 Review Track For 30-day Notice
S097 2008-07-17 Real-time Process
S096 2008-06-17 Real-time Process
S095 2008-06-13 30-day Notice
S094 2008-06-02 Real-time Process
S093 2008-05-30 Real-time Process
S092 2008-05-28 Real-time Process
S091 2008-05-23 30-day Notice
S090 2008-05-22 30-day Notice
S089 2008-05-21 30-day Notice
S088 2008-05-09 Real-time Process
S087 2008-04-15 30-day Notice
S086 2008-04-10 Real-time Process
S085 2008-03-25 Real-time Process
S084 2008-03-19 Real-time Process
S083 2008-03-10 Real-time Process
S082 2008-02-12 Special (immediate Track)
S081 2008-02-06 Real-time Process
S080 2008-02-04 30-day Notice
S079 2008-02-01 Normal 180 Day Track No User Fee
S078 2007-12-26 30-day Notice
S077 2007-12-20 30-day Notice
S076 2007-12-13 30-day Notice
S075 2007-12-06 30-day Notice
S074 2007-10-24 Real-time Process
S073 2007-10-22 Real-time Process
S072 2007-10-19 Normal 180 Day Track No User Fee
S071 2007-09-28 30-day Notice
S070 2007-09-21 Real-time Process
S069 2007-09-20 30-day Notice
S068 2007-09-13 30-day Notice
S067 2007-09-05 Normal 180 Day Track
S066 2007-08-30 30-day Notice
S065 2007-08-23 30-day Notice
S064 2007-08-13 Real-time Process
S063 2007-08-13 Normal 180 Day Track
S062 2007-07-19 30-day Notice
S061 2007-07-19 30-day Notice
S060 2007-07-19 30-day Notice
S059 2007-06-25 30-day Notice
S058 2007-05-07 30-day Notice
S057 2007-04-25 30-day Notice
S056 2007-04-23 Normal 180 Day Track
S055 2007-04-17 30-day Notice
S054 2007-04-16 135 Review Track For 30-day Notice
S053 2007-04-16 30-day Notice
S052 2007-04-13 Real-time Process
S051 2007-04-06 Real-time Process
S050 2007-04-06 Normal 180 Day Track
S049 2007-02-05 Normal 180 Day Track
S048 2006-12-21 30-day Notice
S047 2006-12-13 30-day Notice
S046 2006-11-30 Real-time Process
S045 2006-11-21 Real-time Process
S044 2006-10-25 30-day Notice
S043 2006-10-20 Real-time Process
S042 2006-10-18 30-day Notice
S041 2006-10-12 Real-time Process
S040 2006-10-06 Real-time Process
S039 2006-09-27 30-day Notice
S038
S037 2006-09-07 30-day Notice
S036 2006-09-07 30-day Notice
S035 2006-08-28 30-day Notice
S034 2006-07-19 Normal 180 Day Track
S033 2006-07-13 30-day Notice
S032 2006-07-03 30-day Notice
S031 2006-06-26 Real-time Process
S030 2006-06-07 Real-time Process
S029 2006-05-09 30-day Notice
S028 2006-04-26 30-day Notice
S027
S026
S025 2006-03-30 Real-time Process
S024 2006-03-07 Real-time Process
S023 2006-02-17 Normal 180 Day Track
S022 2006-02-03 Real-time Process
S021 2006-01-25 30-day Notice
S020 2005-12-20 Real-time Process
S019 2005-11-09 Normal 180 Day Track
S018 2005-11-07 Normal 180 Day Track
S017 2005-11-03 30-day Notice
S016 2005-10-26 135 Review Track For 30-day Notice
S015 2005-10-24 Real-time Process
S014 2005-10-11 Real-time Process
S013 2005-10-03 30-day Notice
S012 2005-09-19 30-day Notice
S011 2005-07-29 Real-time Process
S010 2005-06-06 Panel Track
S009 2005-04-21 30-day Notice
S008 2005-04-18 Real-time Process
S007 2005-04-12 Real-time Process
S006 2005-03-02 Real-time Process
S005 2005-01-24 Real-time Process
S004 2004-12-17 Normal 180 Day Track
S003 2004-09-27 Real-time Process
S002 2004-08-16 Normal 180 Day Track No User Fee
S001 2004-07-01 Normal 180 Day Track

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