Approval for the identity adx models xl dr 5386 and dr 5380 pulse generators and programmer software model 3307 v4. 2a. These devices are indicated as follows: implantation of identity adx models5386 and 5380 pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to: syncope, presyncope, fatigue, disorientation, or any combination of those symptoms. Dual-chamber pacing is indicated for those patients exhibiting: sick sinus syndrome, chronic symptomatic second- and third-degree av block, recurrent adams-stokes syndrome, and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal av and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: normal sinus rhythm with only rare episodes of a-v block or sinus arrest, chronic atrial fibrillation and severe physical disability. Af suppression is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
| Device | IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2003-03-03 |
| Decision Date | 2003-03-20 |
| PMA | P880086 |
| Supplement | S093 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P880086 | | Original 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