Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

FDA Premarket Approval P010015 S440

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 add additional tests to the final functional test program at a btle module supplier

DevicePercepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantMEDTRONIC Inc.
Date Received2020-06-09
Decision Date2020-07-08
PMAP010015
SupplementS440
Product CodeLWP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P010015Original Filing
S442 2020-07-02 30-day Notice
S441 2020-06-26 30-day Notice
S440 2020-06-09 30-day Notice
S439
S438
S437 2020-05-21 30-day Notice
S436 2020-05-15 30-day Notice
S435 2020-04-08 30-day Notice
S434 2020-03-25 30-day Notice
S433 2020-03-16 30-day Notice
S432 2020-03-16 30-day Notice
S431 2020-03-12 30-day Notice
S430
S429 2020-02-25 Real-time Process
S428
S427 2020-02-20 30-day Notice
S426 2019-12-23 Real-time Process
S425 2019-12-11 30-day Notice
S424 2019-12-10 30-day Notice
S423 2019-11-25 30-day Notice
S422 2019-11-18 30-day Notice
S421 2019-11-12 30-day Notice
S420 2019-10-08 30-day Notice
S419 2019-09-16 30-day Notice
S418 2019-08-01 30-day Notice
S417 2019-07-29 30-day Notice
S416 2019-07-12 30-day Notice
S415 2019-07-01 30-day Notice
S414 2019-07-01 30-day Notice
S413 2019-06-20 30-day Notice
S412 2019-06-20 30-day Notice
S411
S410
S409 2019-06-10 30-day Notice
S408 2019-05-30 30-day Notice
S407
S406 2019-05-06 30-day Notice
S405 2019-04-29 30-day Notice
S404 2019-04-23 30-day Notice
S403 2019-04-11 30-day Notice
S402 2019-04-03 30-day Notice
S401 2019-03-28 30-day Notice
S400
S399
S398
S397
S396 2019-03-05 30-day Notice
S395 2019-03-04 30-day Notice
S394 2019-02-28 30-day Notice
S393 2019-02-26 30-day Notice
S392 2019-02-25 30-day Notice
S391 2019-02-05 Real-time Process
S390 2019-01-23 30-day Notice
S389 2019-01-15 30-day Notice
S388 2018-12-10 30-day Notice
S387 2018-11-05 30-day Notice
S386 2018-11-01 30-day Notice
S385
S384 2018-10-23 30-day Notice
S383 2018-10-18 30-day Notice
S382 2018-10-15 30-day Notice
S381 2018-10-09 30-day Notice
S380 2018-09-26 30-day Notice
S379 2018-08-29 30-day Notice
S378 2018-08-22 Real-time Process
S377 2018-08-08 30-day Notice
S376 2018-06-28 Normal 180 Day Track No User Fee
S375 2018-06-20 30-day Notice
S374 2018-06-01 30-day Notice
S373 2018-05-15 30-day Notice
S372 2018-05-14 30-day Notice
S371 2018-05-08 30-day Notice
S370 2018-04-23 30-day Notice
S369 2018-04-17 Real-time Process
S368 2018-04-13 Normal 180 Day Track
S367 2018-04-12 30-day Notice
S366 2018-04-12 30-day Notice
S365
S364 2018-04-09 30-day Notice
S363 2018-03-30 30-day Notice
S362 2018-03-28 30-day Notice
S361 2018-03-22 30-day Notice
S360 2018-03-12 30-day Notice
S359 2018-03-12 30-day Notice
S358 2018-03-09 30-day Notice
S357 2018-03-07 Real-time Process
S356 2018-02-08 30-day Notice
S355 2018-02-01 Real-time Process
S354 2018-02-01 30-day Notice
S353 2018-01-29 Real-time Process
S352 2018-01-24 30-day Notice
S351 2017-12-22 30-day Notice
S350
S349 2017-11-29 30-day Notice
S348 2017-11-20 30-day Notice
S347 2017-11-13 30-day Notice
S346 2017-11-07 30-day Notice
S345 2017-10-16 30-day Notice
S344 2017-09-28 30-day Notice
S343 2017-09-05 Real-time Process
S342 2017-08-07 30-day Notice
S341 2017-08-04 30-day Notice
S340 2017-07-21 Normal 180 Day Track
S339 2017-07-20 30-day Notice
S338 2017-07-14 Real-time Process
S337 2017-06-27 30-day Notice
S336 2017-06-23 30-day Notice
S335 2017-06-23 30-day Notice
S334 2017-06-08 30-day Notice
S333 2017-06-07 30-day Notice
S332 2017-05-18 30-day Notice
S331 2017-05-15 30-day Notice
S330 2017-05-12 30-day Notice
S329 2017-05-10 30-day Notice
S328 2017-05-10 30-day Notice
S327 2017-05-10 30-day Notice
S326 2017-04-04 30-day Notice
S325 2017-03-31 30-day Notice
S324 2017-03-29 30-day Notice
S323 2017-03-13 30-day Notice
S322 2017-03-08 30-day Notice
S321 2017-02-09 30-day Notice
S320 2017-01-17 30-day Notice
S319 2017-01-13 30-day Notice
S318 2016-12-15 Normal 180 Day Track
S317 2016-12-06 Normal 180 Day Track
S316 2016-11-28 30-day Notice
S315 2016-11-23 Real-time Process
S314 2016-11-16 Normal 180 Day Track
S313 2016-11-14 30-day Notice
S312 2016-10-05 30-day Notice
S311 2016-09-28 30-day Notice
S310 2016-09-26 30-day Notice
S309 2016-09-12 30-day Notice
S308 2016-09-08 Real-time Process
S307 2016-09-02 30-day Notice
S306 2016-07-22 30-day Notice
S305 2016-07-13 Real-time Process
S304 2016-06-24 Real-time Process
S303 2016-06-24 30-day Notice
S302 2016-06-22 30-day Notice
S301 2016-06-13 30-day Notice
S300 2016-04-26 30-day Notice
S299 2016-04-11 30-day Notice
S298 2016-03-31 30-day Notice
S297 2016-03-18 Real-time Process
S296 2016-03-17 30-day Notice
S295 2016-02-29 30-day Notice
S294 2016-02-25 30-day Notice
S293 2016-02-25 30-day Notice
S292 2016-02-05 30-day Notice
S291 2016-02-02 30-day Notice
S290 2015-12-28 30-day Notice
S289 2015-12-22 30-day Notice
S288 2015-12-18 Real-time Process
S287 2015-12-01 Normal 180 Day Track
S286 2015-10-22 Real-time Process
S285 2015-10-22 Real-time Process
S284 2015-10-19 30-day Notice
S283 2015-10-16 Real-time Process
S282 2015-09-30 30-day Notice
S281
S280 2015-09-10 30-day Notice
S279 2015-08-28 Real-time Process
S278 2015-08-12 30-day Notice
S277 2015-08-11 30-day Notice
S276 2015-07-20 30-day Notice
S275 2015-07-02 Real-time Process
S274 2015-06-01 30-day Notice
S273 2015-05-22 30-day Notice
S272 2015-04-17 30-day Notice
S271 2015-04-14 Real-time Process
S270 2015-03-26 Real-time Process
S269 2015-03-23 30-day Notice
S268 2015-03-06 Real-time Process
S267 2015-02-09 30-day Notice
S266 2015-02-06 30-day Notice
S265 2015-02-05 30-day Notice
S264 2015-02-05 30-day Notice
S263 2015-02-04 30-day Notice
S262 2015-02-02 30-day Notice
S261 2015-02-02 30-day Notice
S260 2015-01-29 30-day Notice
S259 2015-01-23 30-day Notice
S258 2015-01-20 30-day Notice
S257 2015-01-12 30-day Notice
S256 2015-01-12 30-day Notice
S255 2014-12-22 Normal 180 Day Track
S254 2014-12-05 30-day Notice
S253 2014-10-02 30-day Notice
S252 2014-09-29 30-day Notice
S251 2014-09-19 30-day Notice
S250 2014-09-09 30-day Notice
S249 2014-08-27 30-day Notice
S248 2014-08-27 Real-time Process
S247 2014-08-08 30-day Notice
S246 2014-08-01 30-day Notice
S245 2014-07-24 30-day Notice
S244 2014-07-18 Normal 180 Day Track
S243 2014-07-15 30-day Notice
S242 2014-07-02 Real-time Process
S241 2014-06-13 30-day Notice
S240 2014-05-08 30-day Notice
S239 2014-05-01 30-day Notice
S238 2014-03-28 Real-time Process
S237 2014-03-28 Real-time Process
S236 2014-03-18 Real-time Process
S235 2014-03-07 30-day Notice
S234 2014-02-27 30-day Notice
S233 2014-01-31 30-day Notice
S232 2014-01-27 30-day Notice
S231 2013-12-24 30-day Notice
S230 2013-12-23 30-day Notice
S229 2013-12-19 Real-time Process
S228 2013-12-19 30-day Notice
S227 2013-12-18 Normal 180 Day Track
S226 2013-10-30 30-day Notice
S225 2013-10-24 30-day Notice
S224 2013-10-24 30-day Notice
S223 2013-10-17 30-day Notice
S222 2013-09-30 30-day Notice
S221 2013-09-24 30-day Notice
S220 2013-09-17 30-day Notice
S219 2013-09-17 30-day Notice
S218 2013-09-11 30-day Notice
S217 2013-09-06 Normal 180 Day Track No User Fee
S216
S215 2013-08-23 Normal 180 Day Track
S214 2013-08-21 30-day Notice
S213 2013-08-20 30-day Notice
S212 2013-08-12 Real-time Process
S211 2013-07-26 30-day Notice
S210 2013-07-17 30-day Notice
S209 2013-07-11 Real-time Process
S208 2013-07-08 Normal 180 Day Track
S207 2013-07-02 30-day Notice
S206 2013-06-24 30-day Notice
S205 2013-05-29 Panel Track
S204 2013-05-21 30-day Notice
S203 2013-05-17 30-day Notice
S202 2013-05-17 Real-time Process
S201 2013-05-13 Real-time Process
S200 2013-04-30 30-day Notice
S199 2013-04-23 30-day Notice
S198 2013-04-18 Real-time Process
S197 2013-04-10 Normal 180 Day Track No User Fee
S196 2013-03-27 30-day Notice
S195 2013-03-22 30-day Notice
S194 2013-03-11 30-day Notice
S193 2013-03-05 30-day Notice
S192 2013-03-04 30-day Notice
S191 2013-03-04 30-day Notice
S190 2013-02-26 Normal 180 Day Track
S189 2013-02-21 30-day Notice
S188 2013-01-29 30-day Notice
S187 2013-01-22 30-day Notice
S186 2012-12-10 30-day Notice
S185 2012-11-29 30-day Notice
S184 2012-11-21 30-day Notice
S183 2012-11-15 30-day Notice
S182 2012-11-01 Real-time Process
S181 2012-10-05 30-day Notice
S180 2012-09-28 30-day Notice
S179 2012-09-21 30-day Notice
S178 2012-09-10 30-day Notice
S177 2012-09-07 30-day Notice
S176 2012-09-04 30-day Notice
S175 2012-08-24 Real-time Process
S174 2012-08-21 30-day Notice
S173 2012-08-08 30-day Notice
S172 2012-08-07 30-day Notice
S171 2012-08-03 30-day Notice
S170 2012-07-31 30-day Notice
S169 2012-07-25 30-day Notice
S168 2012-07-25 30-day Notice
S167 2012-07-23 30-day Notice
S166 2012-07-17 Normal 180 Day Track
S165 2012-06-29 30-day Notice
S164 2012-06-29 Real-time Process
S163 2012-05-17 30-day Notice
S162 2012-08-21 Normal 180 Day Track
S161
S160 2012-04-04 Real-time Process
S159 2012-04-03 30-day Notice
S158 2012-03-07 30-day Notice
S157 2012-03-07 Normal 180 Day Track
S156 2012-03-05 30-day Notice
S155 2012-02-29 30-day Notice
S154 2012-02-13 30-day Notice
S153
S152 2012-02-03 30-day Notice
S151 2011-12-20 30-day Notice
S150 2011-11-25 30-day Notice
S149 2011-11-23 30-day Notice
S148 2011-11-21 Normal 180 Day Track
S147
S146 2011-11-14 30-day Notice
S145 2011-11-10 Real-time Process
S144 2011-10-26 30-day Notice
S143 2011-10-25 30-day Notice
S142 2011-10-24 135 Review Track For 30-day Notice
S141 2011-10-06 30-day Notice
S140 2011-09-22 30-day Notice
S139 2011-09-19 Real-time Process
S138 2011-09-16 30-day Notice
S137 2011-07-20 30-day Notice
S136 2011-07-18 30-day Notice
S135 2011-07-18 30-day Notice
S134 2011-07-08 30-day Notice
S133 2011-07-08 30-day Notice
S132 2011-07-06 30-day Notice
S131 2011-06-28 30-day Notice
S130 2011-06-08 30-day Notice
S129 2011-06-08 135 Review Track For 30-day Notice
S128 2011-06-07 30-day Notice
S127 2011-05-27 30-day Notice
S126
S125 2011-05-19 Real-time Process
S124 2011-05-13 30-day Notice
S123 2011-05-10 30-day Notice
S122 2011-05-09 30-day Notice
S121 2011-04-26 30-day Notice
S120 2011-04-25 30-day Notice
S119 2011-04-25 Real-time Process
S118 2011-04-19 30-day Notice
S117 2011-04-15 30-day Notice
S116 2011-04-13 30-day Notice
S115 2011-04-11 30-day Notice
S114 2011-04-05 30-day Notice
S113 2011-04-04 30-day Notice
S112 2011-03-22 135 Review Track For 30-day Notice
S111 2011-03-18 135 Review Track For 30-day Notice
S110
S109 2011-02-28 30-day Notice
S108 2011-01-25 30-day Notice
S107 2011-01-04 Normal 180 Day Track
S106 2010-12-09 30-day Notice
S105 2010-12-08 30-day Notice
S104 2010-11-12 30-day Notice
S103 2010-10-26 30-day Notice
S102 2010-10-14 30-day Notice
S101 2010-10-12 30-day Notice
S100
S099 2010-08-13 30-day Notice
S098 2010-07-28 30-day Notice
S097
S096 2010-07-15 30-day Notice
S095 2010-07-15 30-day Notice
S094 2010-07-15 30-day Notice
S093 2010-06-28 135 Review Track For 30-day Notice
S092 2010-06-15 Real-time Process
S091
S090 2010-06-09 30-day Notice
S089 2010-06-02 30-day Notice
S088 2010-05-27 30-day Notice
S087 2010-05-20 Real-time Process
S086 2010-05-17 Normal 180 Day Track
S085 2010-05-03 30-day Notice
S084 2010-03-31 Normal 180 Day Track
S083 2010-03-29 30-day Notice
S082 2010-03-01 Real-time Process
S081 2010-02-19 135 Review Track For 30-day Notice
S080 2010-02-18 30-day Notice
S079 2010-02-18 30-day Notice
S078 2010-01-21 30-day Notice
S077 2010-01-19 30-day Notice
S076 2010-01-13 30-day Notice
S075 2009-12-08 30-day Notice
S074 2009-11-23 30-day Notice
S073 2009-10-08 Real-time Process
S072 2009-09-08 30-day Notice
S071 2009-07-01 135 Review Track For 30-day Notice
S070 2009-06-17 Real-time Process
S069 2009-06-11 30-day Notice
S068 2009-04-06 Real-time Process
S067 2009-03-17 Real-time Process
S066 2009-03-05 30-day Notice
S065 2009-03-02 Normal 180 Day Track
S064 2009-02-23 Real-time Process
S063 2009-02-18 135 Review Track For 30-day Notice
S062 2009-02-09 135 Review Track For 30-day Notice
S061 2009-02-05 30-day Notice
S060 2008-12-15 30-day Notice
S059 2008-12-11 30-day Notice
S058 2008-12-11 30-day Notice
S057 2008-11-20 30-day Notice
S056 2008-11-03 30-day Notice
S055 2008-10-17 Real-time Process
S054
S053 2008-09-19 30-day Notice
S052
S051 2008-08-11 30-day Notice
S050 2008-08-11 135 Review Track For 30-day Notice
S049 2008-08-04 135 Review Track For 30-day Notice
S048 2008-07-28 Normal 180 Day Track
S047 2008-07-25 135 Review Track For 30-day Notice
S046 2008-06-27 135 Review Track For 30-day Notice
S045 2008-06-18 30-day Notice
S044 2008-06-17 30-day Notice
S043 2008-04-14 30-day Notice
S042 2008-03-24 30-day Notice
S041 2008-03-21 30-day Notice
S040
S039 2008-03-04 135 Review Track For 30-day Notice
S038 2008-02-26 30-day Notice
S037 2008-01-25 30-day Notice
S036 2007-11-19 30-day Notice
S035 2007-10-11 30-day Notice
S034 2007-09-28 Normal 180 Day Track
S033 2007-10-09 30-day Notice
S032 2007-09-17 135 Review Track For 30-day Notice
S031 2007-07-26 Real-time Process
S030 2007-06-27 Normal 180 Day Track No User Fee
S029 2007-06-11 Real-time Process
S028 2007-05-18 30-day Notice
S027 2007-03-09 Real-time Process
S026 2007-01-25 30-day Notice
S025 2006-10-17 30-day Notice
S024 2006-07-21 Real-time Process
S023 2006-05-10 135 Review Track For 30-day Notice
S022 2006-02-21 Real-time Process
S021 2006-02-14 Real-time Process
S020 2005-12-30 Normal 180 Day Track No User Fee
S019 2005-12-09 Normal 180 Day Track
S018 2005-12-08 Real-time Process
S017
S016 2005-10-06 Normal 180 Day Track
S015
S014 2004-08-23 Real-time Process
S013 2004-05-19 Normal 180 Day Track No User Fee
S012 2004-02-09 Normal 180 Day Track
S011 2003-08-22 Normal 180 Day Track No User Fee
S010 2003-04-08 Real-time Process
S009 2003-03-05 Normal 180 Day Track
S008 2002-12-03 Normal 180 Day Track
S007 2002-06-28 Normal 180 Day Track
S006 2002-02-27 Normal 180 Day Track
S005 2002-03-04 Normal 180 Day Track
S004 2001-12-03 Normal 180 Day Track
S003 2001-11-19 Normal 180 Day Track
S002 2001-11-05 Special (immediate Track)
S001 2001-09-24 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00885074200729 P010015 003
00885074200743 P010015 003
00885074200736 P010015 003
00613994308658 P010015 012
00885074113364 P010015 012
00885074113371 P010015 012
00613994308658 P010015 012
00613994713667 P010015 084
00613994753304 P010015 084
00613994713667 P010015 084
00613994753304 P010015 084
00643169351905 P010015 227
00643169351905 P010015 227
00643169590595 P010015 247
00643169590588 P010015 247
00643169590595 P010015 247
00643169590588 P010015 247
00643169590571 P010015 247
00643169590571 P010015 247
00643169735675 P010015 317
00643169735651 P010015 317
00643169735644 P010015 317
00643169735637 P010015 317
00643169735675 P010015 317
00643169735682 P010015 317
00643169735651 P010015 317
00643169735682 P010015 317
00643169735644 P010015 317
00643169735637 P010015 317
00643169735668 P010015 317
00643169735668 P010015 317
00643169891425 P010015 338
00643169891401 P010015 338
00643169891449 P010015 338
00643169891456 P010015 338
00643169891418 P010015 338
00643169891432 P010015 338
00643169891401 P010015 338
00643169891456 P010015 338
00643169891449 P010015 338
00643169891432 P010015 338
00643169891425 P010015 338
00643169891418 P010015 338
00763000002046 P010015 399

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