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 the implementation of new biological indicators and reduction of incubation time for the bioindicators for the sterilization process, the use of sterilization process p02 as an alternate sterilization process for cables and adaptors, and parametric release for the sterilization processes.
| Device | Evia DR/SR; Evia DR-T/SR-T; Entovis DR/SR, Entovis DR-T/SR-T; Estella DR/SR; Estella DR-T/SR-T; Effecta D/S; Edora 8 DR/ |
| Classification Name | Implantable Pacemaker Pulse-generator |
| Generic Name | Implantable Pacemaker Pulse-generator |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-06-14 |
| Decision Date | 2019-02-12 |
| PMA | P950037 |
| Supplement | S192 |
| Product Code | DXY |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |