Approval for the integrity afx dr model 5346 pulse generator and programmer software model 3307, v2. 2a. The device is indicated for use in patients with the following permanent conditions, when associated with symptoms including, but not limited to: 1)syncope 2) presyncope 3) fatigue 4) disorientation 5) or any combination of those symptoms. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for those patients exhibiting: 1) sick sinus syndrome 2) chronic, symptomatic second- and third degree av block 3) recurrent adams-stokes syndrome 4) 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: 1) normal sinus rhythm with only rare episodes of av block or sinus arrest 2) chronic atrial fibrillation 3) severe physical disability. Dynamic atrial overdrive is indicated for suppression of atrial tachyarrhythmias including paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.
| Device | INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE GENERATOR AND PROGRAMMER SOFTWARE MODEL 3307, V2.2A |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2001-03-08 |
| Decision Date | 2001-07-11 |
| Notice Date | 2001-10-11 |
| PMA | P880086 |
| Supplement | S083 |
| Product Code | DXY |
| Docket Number | 01M-0462 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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