Modification to the labeling to include a "cellular tested" logo to the shelf package of the following pacemaker models: phoenix 2 (2005/2008/2009), paragon (2010/2011/2012), paragon ii (2016), synchrony (2020), synchrony ii (2022/2023), synchrony iii (2028/2029), solus (2002/2003), solus ii (2006/2007), trilogy (2350/2308/2250) and revision of the patient manual to include the logo and language informing the patient that no special cell phone precautions need to be taken by patients receiving these models
| Device | SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 1996-03-12 |
| Decision Date | 1996-10-09 |
| PMA | P880086 |
| Supplement | S035 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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