This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a larger oi-circuit capacitor and modification to the ceramic feedthrough.
Device | VARIOUS MODELS OF PHILOS/PHILOS, AXIOS, PROTOS PULSE GENERATOR |
Classification Name | Pulse Generator, Permanent, Implantable |
Generic Name | Pulse Generator, Permanent, Implantable |
Applicant | BIOTRONIK, INC. |
Date Received | 2008-02-04 |
Decision Date | 2008-07-11 |
PMA | P950037 |
Supplement | S057 |
Product Code | NVZ |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
Supplement Number | Date | Supplement Type |
---|---|---|
P950037 | Original Filing | |
S243 | 2022-11-23 | 30-day Notice |
S242 | ||
S241 | 2022-11-10 | 30-day Notice |
S240 | 2022-09-26 | Real-time Process |
S239 | 2022-09-22 | 30-day Notice |
S238 | 2022-08-29 | 30-day Notice |
S237 | 2022-08-03 | 30-day Notice |
S236 | 2022-06-17 | 30-day Notice |
S235 | 2022-02-17 | 30-day Notice |
S234 | ||
S233 | 2022-01-05 | Normal 180 Day Track No User Fee |
S232 | ||
S231 | 2021-11-24 | 30-day Notice |
S230 | 2021-09-30 | 30-day Notice |
S229 | ||
S228 | ||
S227 | 2021-07-21 | 30-day Notice |
S226 | 2021-06-21 | 30-day Notice |
S225 | ||
S224 | 2021-06-01 | 30-day Notice |
S223 | 2021-05-05 | 30-day Notice |
S222 | 2021-05-04 | 30-day Notice |
S221 | 2021-03-18 | 30-day Notice |
S220 | ||
S219 | 2021-03-11 | 30-day Notice |
S218 | 2020-11-23 | 30-day Notice |
S217 | 2020-11-02 | 30-day Notice |
S216 | 2020-10-28 | 30-day Notice |
S215 | ||
S214 | 2020-08-10 | Real-time Process |
S213 | ||
S212 | 2020-03-26 | 30-day Notice |
S211 | ||
S210 | ||
S209 | 2019-12-31 | 30-day Notice |
S208 | 2019-11-26 | 30-day Notice |
S207 | ||
S206 | ||
S205 | 2019-09-17 | 30-day Notice |
S204 | 2019-08-15 | Real-time Process |
S203 | 2019-06-20 | 30-day Notice |
S202 | ||
S201 | 2019-04-23 | 30-day Notice |
S200 | ||
S199 | 2018-12-10 | Normal 180 Day Track No User Fee |
S198 | 2018-11-01 | Normal 180 Day Track |
S197 | 2018-09-12 | Normal 180 Day Track |
S196 | 2018-09-04 | 30-day Notice |
S195 | 2018-08-22 | Real-time Process |
S194 | 2018-07-13 | Normal 180 Day Track |
S193 | 2018-07-10 | 30-day Notice |
S192 | 2018-06-14 | 135 Review Track For 30-day Notice |
S191 | 2018-05-18 | 30-day Notice |
S190 | 2018-05-17 | Real-time Process |
S189 | 2018-05-14 | 30-day Notice |
S188 | ||
S187 | 2018-02-23 | 135 Review Track For 30-day Notice |
S186 | 2018-02-09 | Normal 180 Day Track |
S185 | 2018-01-22 | 30-day Notice |
S184 | 2017-11-20 | 30-day Notice |
S183 | 2017-11-20 | Real-time Process |
S182 | 2017-10-18 | Real-time Process |
S181 | 2017-08-23 | Real-time Process |
S180 | 2017-08-14 | 30-day Notice |
S179 | 2017-06-06 | Real-time Process |
S178 | 2017-06-02 | 30-day Notice |
S177 | 2017-05-24 | Real-time Process |
S176 | 2017-05-05 | Real-time Process |
S175 | 2017-04-20 | Real-time Process |
S174 | 2017-04-12 | Real-time Process |
S173 | 2017-02-16 | Normal 180 Day Track |
S172 | 2017-01-03 | 30-day Notice |
S171 | 2016-12-07 | Normal 180 Day Track |
S170 | 2016-11-21 | 30-day Notice |
S169 | 2016-11-21 | Real-time Process |
S168 | 2016-09-23 | 30-day Notice |
S167 | 2016-08-08 | Normal 180 Day Track |
S166 | 2016-07-28 | Normal 180 Day Track |
S165 | 2016-06-09 | Real-time Process |
S164 | 2016-06-06 | Normal 180 Day Track |
S163 | 2016-05-31 | 30-day Notice |
S162 | 2016-03-24 | Real-time Process |
S161 | 2015-12-23 | Normal 180 Day Track |
S160 | 2015-12-16 | Real-time Process |
S159 | ||
S158 | 2015-08-03 | 30-day Notice |
S157 | 2015-06-09 | 30-day Notice |
S156 | 2015-06-01 | Normal 180 Day Track |
S155 | 2015-05-27 | 30-day Notice |
S154 | 2015-05-19 | 30-day Notice |
S153 | 2015-04-29 | 135 Review Track For 30-day Notice |
S152 | 2015-04-16 | 30-day Notice |
S151 | 2015-04-16 | Normal 180 Day Track |
S150 | 2015-03-23 | Normal 180 Day Track |
S149 | 2015-03-06 | 135 Review Track For 30-day Notice |
S148 | 2015-02-13 | Real-time Process |
S147 | 2015-02-04 | 30-day Notice |
S146 | 2015-01-08 | 30-day Notice |
S145 | 2014-11-03 | 30-day Notice |
S144 | 2014-10-31 | 30-day Notice |
S143 | 2014-10-14 | 30-day Notice |
S142 | 2014-09-25 | Normal 180 Day Track |
S141 | 2014-09-24 | 30-day Notice |
S140 | 2014-09-19 | 30-day Notice |
S139 | 2014-08-04 | Normal 180 Day Track |
S138 | 2014-07-28 | Normal 180 Day Track |
S137 | 2014-06-23 | Normal 180 Day Track |
S136 | 2014-06-23 | 30-day Notice |
S135 | 2014-06-13 | Real-time Process |
S134 | 2014-05-30 | 30-day Notice |
S133 | 2013-12-09 | 30-day Notice |
S132 | 2013-11-25 | Normal 180 Day Track |
S131 | 2013-11-07 | Real-time Process |
S130 | 2013-11-05 | 30-day Notice |
S129 | 2013-11-05 | 30-day Notice |
S128 | 2013-08-15 | Real-time Process |
S127 | 2013-07-29 | Real-time Process |
S126 | 2013-07-16 | 30-day Notice |
S125 | 2013-06-03 | Real-time Process |
S124 | 2013-05-20 | Real-time Process |
S123 | 2013-04-29 | 30-day Notice |
S122 | 2013-04-22 | 30-day Notice |
S121 | 2013-04-03 | Real-time Process |
S120 | ||
S119 | 2013-02-05 | Real-time Process |
S118 | 2013-01-14 | 30-day Notice |
S117 | 2012-12-21 | Real-time Process |
S116 | 2012-12-18 | Normal 180 Day Track |
S115 | ||
S114 | 2012-12-03 | 30-day Notice |
S113 | 2012-11-19 | Real-time Process |
S112 | 2012-09-07 | 30-day Notice |
S111 | 2012-08-10 | Real-time Process |
S110 | 2012-07-02 | Real-time Process |
S109 | 2012-06-18 | Real-time Process |
S108 | 2012-04-05 | Real-time Process |
S107 | 2012-04-02 | 135 Review Track For 30-day Notice |
S106 | ||
S105 | 2012-03-01 | Normal 180 Day Track |
S104 | 2012-02-17 | Real-time Process |
S103 | 2012-02-06 | 30-day Notice |
S102 | 2012-01-30 | Real-time Process |
S101 | 2012-01-27 | Real-time Process |
S100 | 2011-11-02 | Normal 180 Day Track |
S099 | 2011-10-03 | Real-time Process |
S098 | 2011-08-19 | Normal 180 Day Track |
S097 | 2011-06-16 | 135 Review Track For 30-day Notice |
S096 | 2011-04-11 | Real-time Process |
S095 | 2011-03-23 | 30-day Notice |
S094 | 2011-03-10 | 30-day Notice |
S093 | ||
S092 | 2010-12-13 | Real-time Process |
S091 | 2010-12-10 | Normal 180 Day Track |
S090 | 2010-11-09 | 30-day Notice |
S089 | 2010-10-28 | Normal 180 Day Track |
S088 | 2010-10-06 | Normal 180 Day Track |
S087 | ||
S086 | 2010-08-20 | 30-day Notice |
S085 | 2010-08-12 | 30-day Notice |
S084 | 2010-07-14 | Normal 180 Day Track |
S083 | 2010-06-08 | Normal 180 Day Track |
S082 | 2010-05-28 | Normal 180 Day Track No User Fee |
S081 | 2010-05-11 | Real-time Process |
S080 | 2010-04-13 | 30-day Notice |
S079 | 2010-03-23 | Normal 180 Day Track |
S078 | 2010-03-02 | Real-time Process |
S077 | 2010-02-12 | 30-day Notice |
S076 | 2009-11-25 | Real-time Process |
S075 | ||
S074 | 2009-11-24 | Real-time Process |
S073 | 2009-09-10 | Real-time Process |
S072 | 2009-07-08 | Normal 180 Day Track |
S071 | 2009-03-23 | Real-time Process |
S070 | 2009-03-06 | 30-day Notice |
S069 | 2009-02-13 | Real-time Process |
S068 | 2009-01-26 | Normal 180 Day Track |
S067 | 2008-11-17 | Normal 180 Day Track |
S066 | 2008-10-31 | Real-time Process |
S065 | 2008-10-17 | Real-time Process |
S064 | 2008-10-17 | Real-time Process |
S063 | 2008-09-05 | 30-day Notice |
S062 | 2008-06-04 | 135 Review Track For 30-day Notice |
S061 | 2008-05-21 | Real-time Process |
S060 | 2008-05-14 | Real-time Process |
S059 | 2008-05-14 | Normal 180 Day Track |
S058 | 2008-03-18 | Real-time Process |
S057 | 2008-02-04 | Normal 180 Day Track |
S056 | 2008-01-07 | Real-time Process |
S055 | 2007-10-23 | Real-time Process |
S054 | 2007-08-13 | Normal 180 Day Track |
S053 | 2007-07-13 | Normal 180 Day Track |
S052 | 2007-06-25 | 30-day Notice |
S051 | 2007-04-10 | Real-time Process |
S050 | 2007-01-22 | Real-time Process |
S049 | 2007-01-11 | Real-time Process |
S048 | 2006-12-13 | Real-time Process |
S047 | 2006-10-12 | Real-time Process |
S046 | 2006-09-11 | Normal 180 Day Track |
S045 | 2006-06-29 | Real-time Process |
S044 | 2006-04-10 | 135 Review Track For 30-day Notice |
S043 | 2006-02-24 | Real-time Process |
S042 | 2005-11-09 | Normal 180 Day Track |
S041 | 2005-09-26 | Real-time Process |
S040 | ||
S039 | 2004-08-09 | Normal 180 Day Track |
S038 | 2004-05-27 | Normal 180 Day Track |
S037 | 2004-02-12 | Real-time Process |
S036 | 2003-11-03 | Normal 180 Day Track |
S035 | 2003-07-28 | Normal 180 Day Track |
S034 | 2003-07-14 | Normal 180 Day Track |
S033 | 2003-06-24 | Normal 180 Day Track |
S032 | 2003-02-28 | Normal 180 Day Track |
S031 | 2003-02-06 | Real-time Process |
S030 | 2003-01-09 | Normal 180 Day Track |
S029 | 2002-11-20 | 30-day Notice |
S028 | 2002-11-15 | Real-time Process |
S027 | ||
S026 | ||
S025 | ||
S024 | 2001-12-31 | Normal 180 Day Track |
S023 | 2002-02-11 | Normal 180 Day Track |
S022 | 2001-09-28 | Real-time Process |
S021 | 2001-07-27 | Normal 180 Day Track |
S020 | 2001-06-11 | Normal 180 Day Track |
S019 | 2001-02-23 | Normal 180 Day Track |
S018 | 2001-01-12 | Real-time Process |
S017 | 2000-09-27 | Normal 180 Day Track |
S016 | 2000-10-06 | Real-time Process |
S015 | 2000-08-07 | Real-time Process |
S014 | 2000-05-30 | 30-day Notice |
S013 | 2000-05-08 | Normal 180 Day Track |
S012 | 2000-05-15 | Real-time Process |
S011 | 2000-04-13 | Real-time Process |
S010 | ||
S009 | 1999-05-14 | Real-time Process |
S008 | 1999-03-01 | Normal 180 Day Track |
S007 | 1999-01-20 | Normal 180 Day Track |
S006 | 1998-12-10 | Normal 180 Day Track |
S005 | 1998-10-26 | Real-time Process |
S004 | 1998-08-31 | Real-time Process |
S003 | 1998-06-09 | Real-time Process |
S002 | 1998-07-06 | Real-time Process |
S001 | 1997-03-31 | Normal 180 Day Track |