Approval for the model 3330 version 3. 0 software for use on the model 3650 merlin patient care system which adds the support for the use of merlin with the victory, epic ii and frontier ii pulse generator families.
| Device | SELECTED MODELS OF SYNCHRONY & AFFINITY FAMILIES OF PACEMAKERS |
| Classification Name | Pulse Generator, Permanent, Implantable |
| Generic Name | Pulse Generator, Permanent, Implantable |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2006-03-07 |
| Decision Date | 2006-04-05 |
| PMA | P880086 |
| Supplement | S117 |
| Product Code | NVZ |
| 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