Approval to modify the header design of a currently marketed device. The device, as modified, will be marketed under the trade name verity adx xl vdr model 5456i and is indicated as follows: the verity adx xl vdr model 5456i is indicated for use only with av plus model 1328c or 1358c single-pass in-line quadripolar leads (the verity adx xl vdr pacing system). The verity adx xl vdr pacing system is intended to provide vdd or vddr pacing for patients with a healthy sinus node and av conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete av block when: a) atrial contribution is needed for hemodynamic benefit, and b) pacemaker syndrome had existed or is anticipated. Additional indications include normal sinus rhythm and normal av conduction in patients who intermittently need ventricular pacing.
| Device | VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2003-12-02 |
| Decision Date | 2004-01-30 |
| PMA | P880086 |
| Supplement | S098 |
| 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