PRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,

Implantable Pacemaker Pulse-generator

FDA Premarket Approval P880086 S103

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

Approval for pre-molded header design. The device, as modified, will be marketed under the trade names integrity dr model 5336, identity dr model 5370, identity adx dr model 5380, identity adx vdr model 5480, and integrity adx dr model 5360.

DevicePRE-MOLDED HEADER CONNECTOR DESIGN FOR THE INTEGRITY DR MODEL 5336, IDENTITY DR MODEL 5370, IDENTITY ADX DR MODEL 5380,
Classification NameImplantable Pacemaker Pulse-generator
Generic NameImplantable Pacemaker Pulse-generator
ApplicantSt. Jude Medical, Inc.
Date Received2005-02-22
Decision Date2005-04-06
PMAP880086
SupplementS103
Product CodeDXY
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342

Supplemental Filings

Supplement NumberDateSupplement Type
P880086Original Filing
S325 2022-07-27 Real-time Process
S324 2022-07-01 30-day Notice
S323 2022-03-07 Real-time Process
S322 2021-10-18 Real-time Process
S321 2021-07-08 Normal 180 Day Track
S320 2021-06-28 30-day Notice
S319 2021-04-02 Real-time Process
S318 2021-03-12 30-day Notice
S317
S316 2020-11-25 30-day Notice
S315 2020-10-21 30-day Notice
S314 2020-09-30 30-day Notice
S313 2020-04-24 30-day Notice
S312 2020-02-13 30-day Notice
S311 2019-12-10 30-day Notice
S310 2019-12-09 30-day Notice
S309 2019-11-25 30-day Notice
S308
S307
S306
S305 2018-11-20 30-day Notice
S304 2018-10-29 Real-time Process
S303 2018-09-28 30-day Notice
S302 2018-09-04 30-day Notice
S301 2018-07-17 30-day Notice
S300 2018-05-21 30-day Notice
S299
S298 2018-04-10 30-day Notice
S297 2018-04-05 30-day Notice
S296 2018-02-07 30-day Notice
S295 2018-01-31 30-day Notice
S294 2018-01-29 30-day Notice
S293 2018-01-18 Normal 180 Day Track
S292 2017-12-21 30-day Notice
S291 2017-12-07 30-day Notice
S290 2017-10-30 Real-time Process
S289 2017-10-10 30-day Notice
S288 2017-09-21 30-day Notice
S287 2017-08-16 30-day Notice
S286 2017-07-31 Real-time Process
S285 2017-07-31 30-day Notice
S284 2017-07-31 30-day Notice
S283 2017-05-17 Normal 180 Day Track
S282 2017-04-06 30-day Notice
S281 2017-02-28 30-day Notice
S280 2017-02-07 Real-time Process
S279 2017-02-01 Real-time Process
S278 2017-01-30 30-day Notice
S277 2017-01-26 30-day Notice
S276 2016-12-14 Real-time Process
S275 2016-08-30 30-day Notice
S274 2016-07-25 30-day Notice
S273 2016-04-26 Real-time Process
S272 2016-04-04 Real-time Process
S271 2016-03-31 30-day Notice
S270 2016-01-27 30-day Notice
S269 2016-01-27 30-day Notice
S268
S267 2015-12-18 Real-time Process
S266 2015-12-07 30-day Notice
S265 2015-11-25 30-day Notice
S264 2015-11-12 30-day Notice
S263 2015-10-26 135 Review Track For 30-day Notice
S262 2015-09-29 Real-time Process
S261 2015-09-15 Normal 180 Day Track
S260 2015-08-17 Normal 180 Day Track
S259 2015-08-10 30-day Notice
S258 2015-07-23 Real-time Process
S257 2015-05-19 Real-time Process
S256 2015-04-15 30-day Notice
S255 2015-02-11 Normal 180 Day Track
S254 2015-02-04 Real-time Process
S253 2014-12-18 Real-time Process
S252
S251 2014-11-03 Real-time Process
S250 2014-10-27 30-day Notice
S249 2014-10-20 Real-time Process
S248 2014-10-06 Real-time Process
S247 2014-09-15 Real-time Process
S246 2014-08-07 30-day Notice
S245 2014-07-02 Normal 180 Day Track
S244 2014-06-12 30-day Notice
S243 2014-05-28 30-day Notice
S242 2014-04-15 Real-time Process
S241 2014-04-08 30-day Notice
S240 2014-03-25 30-day Notice
S239 2014-02-05 30-day Notice
S238 2014-01-24 Real-time Process
S237 2013-11-21 Normal 180 Day Track
S236 2013-11-05 30-day Notice
S235 2013-09-05 30-day Notice
S234 2013-08-06 30-day Notice
S233 2013-05-02 30-day Notice
S232 2013-04-15 30-day Notice
S231 2012-12-11 135 Review Track For 30-day Notice
S230 2012-12-05 Normal 180 Day Track
S229 2012-11-14 Normal 180 Day Track
S228
S227 2012-09-28 30-day Notice
S226 2012-09-13 30-day Notice
S225 2012-08-27 30-day Notice
S224 2012-08-16 30-day Notice
S223 2012-08-16 Real-time Process
S222 2012-08-15 30-day Notice
S221 2012-07-11 Real-time Process
S220 2012-07-11 Normal 180 Day Track
S219 2012-05-30 Real-time Process
S218 2012-04-03 30-day Notice
S217 2012-02-29 Real-time Process
S216 2012-02-22 Real-time Process
S215 2012-01-10 30-day Notice
S214
S213 2011-12-05 30-day Notice
S212 2011-11-30 135 Review Track For 30-day Notice
S211 2011-11-01 Normal 180 Day Track
S210 2011-09-07 Normal 180 Day Track No User Fee
S209 2011-08-31 Real-time Process
S208 2011-08-08 Real-time Process
S207 2011-06-28 Real-time Process
S206 2011-06-28 Real-time Process
S205 2011-06-08
S204 2011-05-06 Real-time Process
S203 2011-05-02 Normal 180 Day Track
S202 2011-04-19 Normal 180 Day Track
S201 2011-04-05 30-day Notice
S200
S199 2011-03-22 135 Review Track For 30-day Notice
S198 2011-03-09 135 Review Track For 30-day Notice
S197 2011-01-24 30-day Notice
S196 2010-12-16 30-day Notice
S195 2010-11-23 Normal 180 Day Track
S194 2010-10-12 30-day Notice
S193 2010-08-16 Normal 180 Day Track No User Fee
S192 2010-07-30 Real-time Process
S191 2010-06-18 30-day Notice
S190 2010-06-17 30-day Notice
S189 2010-06-04 Normal 180 Day Track
S188 2010-05-21 30-day Notice
S187 2010-05-21 30-day Notice
S186 2010-03-26 30-day Notice
S185 2010-02-04 30-day Notice
S184 2009-12-24 30-day Notice
S183 2009-11-25 Normal 180 Day Track No User Fee
S182 2009-11-16 30-day Notice
S181 2009-10-02 135 Review Track For 30-day Notice
S180 2009-09-28 30-day Notice
S179
S178 2009-09-14 Real-time Process
S177 2009-06-18 30-day Notice
S176 2009-06-10 30-day Notice
S175 2009-05-14 30-day Notice
S174 2009-01-22 Normal 180 Day Track
S173 2008-12-31 Real-time Process
S172 2008-12-19 30-day Notice
S171 2008-12-18 30-day Notice
S170 2008-11-07 30-day Notice
S169 2008-10-14 30-day Notice
S168 2008-09-02 30-day Notice
S167 2008-08-04 135 Review Track For 30-day Notice
S166 2008-07-30 Real-time Process
S165 2008-06-13 30-day Notice
S164 2008-06-02 Real-time Process
S163 2008-05-21 30-day Notice
S162 2008-03-25 Real-time Process
S161 2008-02-15 Normal 180 Day Track No User Fee
S160 2008-02-01 Normal 180 Day Track No User Fee
S159 2008-01-22 30-day Notice
S158 2007-11-16 30-day Notice
S157 2007-11-13 30-day Notice
S156 2007-10-24 Real-time Process
S155 2007-10-19 Normal 180 Day Track No User Fee
S154 2007-09-28 30-day Notice
S153 2007-09-28 30-day Notice
S152 2007-09-24 30-day Notice
S151 2007-09-21 Real-time Process
S150 2007-06-20 Real-time Process
S149 2007-06-01 135 Review Track For 30-day Notice
S148 2007-05-21 Real-time Process
S147 2007-05-16 30-day Notice
S146 2007-04-24 Real-time Process
S145 2007-04-23 Normal 180 Day Track
S144 2007-04-17 30-day Notice
S143 2007-04-13 Real-time Process
S142 2007-04-06 Real-time Process
S141 2006-12-22 135 Review Track For 30-day Notice
S140 2006-12-20 135 Review Track For 30-day Notice
S139 2006-12-11 Normal 180 Day Track
S138 2006-11-01 30-day Notice
S137 2006-10-23 30-day Notice
S136 2006-10-20 Real-time Process
S135 2006-10-12 30-day Notice
S134 2006-10-12 Real-time Process
S133 2006-10-06 Real-time Process
S132 2006-09-27 30-day Notice
S131 2006-09-25 30-day Notice
S130 2006-09-13 30-day Notice
S129 2006-09-12 30-day Notice
S128 2006-09-07 30-day Notice
S127 2006-08-24 30-day Notice
S126 2006-08-16 Real-time Process
S125 2006-07-18 30-day Notice
S124 2006-07-13 30-day Notice
S123 2006-06-27 Normal 180 Day Track
S122 2006-06-07 Real-time Process
S121 2006-05-15 30-day Notice
S120
S119
S118 2006-03-30 Real-time Process
S117 2006-03-07 Real-time Process
S116 2006-02-17 Normal 180 Day Track
S115 2006-02-03 Real-time Process
S114 2006-01-25 Normal 180 Day Track
S113 2006-01-06 Real-time Process
S112 2005-11-16 135 Review Track For 30-day Notice
S111 2005-11-14 Normal 180 Day Track No User Fee
S110 2005-10-07 Real-time Process
S109 2005-09-16 30-day Notice
S108 2005-08-30 Normal 180 Day Track
S107
S106 2005-07-27 30-day Notice
S105 2005-07-26 30-day Notice
S104 2005-06-20 30-day Notice
S103 2005-02-22 Real-time Process
S102 2005-01-24 Real-time Process
S101 2004-08-30 Real-time Process
S100 2004-05-17 Normal 180 Day Track
S099 2004-03-22 Real-time Process
S098 2003-12-02 Real-time Process
S097 2003-10-07 Real-time Process
S096 2003-09-11 Real-time Process
S095 2003-08-05 Real-time Process
S094 2003-04-14 Real-time Process
S093 2003-03-03 Real-time Process
S092 2003-02-07 Normal 180 Day Track
S091 2002-12-24 Real-time Process
S090 2002-12-04 Real-time Process
S089 2002-08-02 Real-time Process
S088 2002-07-17 Real-time Process
S087 2001-11-29 Real-time Process
S086 2001-10-29 Real-time Process
S085 2001-09-05 Real-time Process
S084 2001-08-10 Real-time Process
S083 2001-03-08 Normal 180 Day Track
S082 2001-02-09 Real-time Process
S081 2000-11-16 Real-time Process
S080 2000-11-02 Real-time Process
S079 2000-10-16 Special (immediate Track)
S078 2000-09-07 Real-time Process
S077 2000-08-11 Normal 180 Day Track
S076 2000-08-01 Real-time Process
S075 2000-08-01 Real-time Process
S074
S073 2000-05-25 Real-time Process
S072 2000-05-24 Real-time Process
S071 2000-03-13 Real-time Process
S070 2000-03-13 Real-time Process
S069 2000-01-31 30-day Notice
S068 1999-09-07 Real-time Process
S067 1999-07-22 Normal 180 Day Track
S066 1999-07-06 Real-time Process
S065 1999-07-02 135 Review Track For 30-day Notice
S064 1999-07-01 Real-time Process
S063 1999-07-02 Real-time Process
S062 1999-05-25 30-day Notice
S061 1999-05-21 Real-time Process
S060 1999-03-24 Real-time Process
S059
S058
S057
S056 1998-10-02 Real-time Process
S055
S054
S053 1998-09-11 Real-time Process
S052 1998-09-09 30-day Notice
S051 1998-07-30 Normal 180 Day Track
S050 1998-07-30 Normal 180 Day Track
S049 1998-06-30 Real-time Process
S048 1998-06-12 Real-time Process
S047 1998-06-12 Normal 180 Day Track
S046 1998-03-06 Normal 180 Day Track
S045 1998-03-13 Normal 180 Day Track
S044
S043 1997-12-08 Real-time Process
S042
S041 1997-07-31 Normal 180 Day Track
S040 1996-11-08 Normal 180 Day Track
S039 1996-08-14 Normal 180 Day Track
S038 1996-08-12 Normal 180 Day Track
S037 1996-08-01 Normal 180 Day Track
S036 1996-03-21 Normal 180 Day Track
S035 1996-03-12 Normal 180 Day Track
S034 1995-10-02 Normal 180 Day Track
S033 1995-08-02 Normal 180 Day Track
S032 1995-08-02 Normal 180 Day Track
S031 1995-04-20 Special (immediate Track)
S030 1994-11-16 Normal 180 Day Track
S029 1994-04-26 Normal 180 Day Track
S028 1994-04-14 Normal 180 Day Track
S027 1993-11-30 Normal 180 Day Track
S026 1993-08-23 Normal 180 Day Track
S025 1993-05-21 Normal 180 Day Track
S024 1993-04-21 Normal 180 Day Track
S023 1993-04-08 Normal 180 Day Track
S022 1993-04-01 Normal 180 Day Track
S021 1993-03-11 Normal 180 Day Track
S020 1992-06-22 Normal 180 Day Track
S019
S018 1992-02-11 Normal 180 Day Track
S017 1992-01-29 Normal 180 Day Track
S016 1992-01-14 Normal 180 Day Track
S015 1991-10-15 Normal 180 Day Track
S014 1991-08-23 Normal 180 Day Track
S013 1991-07-24 Normal 180 Day Track
S012 1991-04-23 Normal 180 Day Track
S011 1991-04-15 Normal 180 Day Track
S010 1991-03-29 Normal 180 Day Track
S009 1990-12-13 Normal 180 Day Track
S008 1990-10-29 Normal 180 Day Track
S007 1990-10-02 Normal 180 Day Track
S006 1990-09-13 Normal 180 Day Track
S005 1989-11-13 Normal 180 Day Track
S004 1989-11-03 Normal 180 Day Track
S003 1989-10-03 Normal 180 Day Track
S002 1989-08-25 Normal 180 Day Track
S001 1989-08-25 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734500449 P880086 077
H758537007 P880086 086
05414734006880 P880086 086
H758517207 P880086 086
05414734006903 P880086 093
H758538008 P880086 093
H758505608 P880086 094
05414734006910 P880086 094
H758548009 P880086 094
05414734006866 P880086 094
H758536006 P880086 094
05414734006842 P880086 094
H758515609 P880086 094
05414734006774 P880086 094
H758516004 P880086 094
H758518006 P880086 094
05414734006811 P880086 094
05414734006828 P880086 094
05414734006835 P880086 094
05414734010474 P880086 098
H758561004 P880086 108
H758581006 P880086 108
05414734009553 P880086 108
H758562005 P880086 139
H758582007 P880086 139
05414734501620 P880086 139
05414734501712 P880086 146
H758PM221001 P880086 174
05414734503600 P880086 174
05414734502757 P880086 174
05414734502740 P880086 174
05414734504713 P880086 204
05414734504744 P880086 204
05414734504737 P880086 204
05414734504720 P880086 204
05414734507097 P880086 230
05414734507059 P880086 230
05414734507066 P880086 230
05414734507073 P880086 230
05414734507080 P880086 230
05414734507042 P880086 230
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.