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.
| Device | Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS138 Date Received08/03/2022 Decision Date08/22/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-08-22 |
| PMA | P070008 |
| Supplement | S138 |
| Product Code | NKE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS138 Date Received08/03/2022 Decision Date08/22/2022 Product Code NKE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement optimization Of The Automated Header Milling Process |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070008 | Original Filing | |
| S143 | 2022-11-15 | Real-time Process |
| S142 | 2022-11-10 | 30-day Notice |
| S141 | 2022-10-18 | 30-day Notice |
| S140 | 2022-09-22 | 30-day Notice |
| S139 | 2022-08-29 | 30-day Notice |
| S138 | 2022-08-03 | 30-day Notice |
| S137 | 2022-06-17 | 30-day Notice |
| S136 | 2022-02-07 | Real-time Process |
| S135 | 2022-02-01 | 30-day Notice |
| S134 | ||
| S133 | 2021-11-24 | 30-day Notice |
| S132 | 2021-09-30 | 30-day Notice |
| S131 | ||
| S130 | ||
| S129 | 2021-08-05 | 30-day Notice |
| S128 | 2021-07-21 | 30-day Notice |
| S127 | 2021-06-21 | 30-day Notice |
| S126 | ||
| S125 | 2021-05-05 | 30-day Notice |
| S124 | 2021-05-04 | 30-day Notice |
| S123 | 2021-03-18 | 30-day Notice |
| S122 | ||
| S121 | 2020-11-23 | 30-day Notice |
| S120 | 2020-11-02 | 30-day Notice |
| S119 | 2020-10-28 | 30-day Notice |
| S118 | ||
| S117 | 2020-08-10 | Real-time Process |
| S116 | ||
| S115 | 2020-03-16 | Real-time Process |
| S114 | 2020-02-25 | Real-time Process |
| S113 | 2020-02-18 | 30-day Notice |
| S112 | ||
| S111 | 2019-12-31 | 30-day Notice |
| S110 | ||
| S109 | ||
| S108 | 2019-09-17 | 30-day Notice |
| S107 | 2019-08-30 | Normal 180 Day Track No User Fee |
| S106 | 2019-08-15 | Real-time Process |
| S105 | 2019-06-20 | 30-day Notice |
| S104 | ||
| S103 | 2019-04-23 | 30-day Notice |
| S102 | 2019-03-18 | 30-day Notice |
| S101 | ||
| S100 | 2019-01-23 | 30-day Notice |
| S099 | ||
| S098 | 2018-09-12 | Normal 180 Day Track |
| S097 | 2018-08-22 | Real-time Process |
| S096 | 2018-07-13 | Normal 180 Day Track |
| S095 | 2018-07-10 | 30-day Notice |
| S094 | 2018-06-14 | 135 Review Track For 30-day Notice |
| S093 | 2018-05-18 | 30-day Notice |
| S092 | 2018-05-17 | Real-time Process |
| S091 | 2018-02-23 | 135 Review Track For 30-day Notice |
| S090 | 2018-02-09 | Normal 180 Day Track |
| S089 | 2018-01-22 | 30-day Notice |
| S088 | 2017-11-20 | Real-time Process |
| S087 | 2017-10-18 | Real-time Process |
| S086 | 2017-07-03 | 30-day Notice |
| S085 | 2017-06-06 | Real-time Process |
| S084 | 2017-05-24 | Real-time Process |
| S083 | 2017-05-05 | Real-time Process |
| S082 | 2017-04-20 | Real-time Process |
| S081 | 2017-02-16 | Normal 180 Day Track |
| S080 | 2017-01-03 | 30-day Notice |
| S079 | 2016-12-07 | Normal 180 Day Track |
| S078 | ||
| S077 | 2016-11-21 | Real-time Process |
| S076 | 2016-08-08 | Normal 180 Day Track |
| S075 | 2016-07-28 | Normal 180 Day Track |
| S074 | 2016-06-06 | Normal 180 Day Track |
| S073 | 2016-05-31 | 30-day Notice |
| S072 | 2016-03-24 | Real-time Process |
| S071 | 2016-03-03 | 30-day Notice |
| S070 | 2015-12-23 | Normal 180 Day Track |
| S069 | 2015-12-16 | Real-time Process |
| S068 | 2015-08-03 | 30-day Notice |
| S067 | 2015-06-09 | 30-day Notice |
| S066 | 2015-05-27 | 30-day Notice |
| S065 | 2015-05-19 | 30-day Notice |
| S064 | 2015-04-29 | 135 Review Track For 30-day Notice |
| S063 | 2015-04-16 | Normal 180 Day Track |
| S062 | 2015-03-23 | Normal 180 Day Track |
| S061 | 2015-03-06 | 135 Review Track For 30-day Notice |
| S060 | 2015-02-13 | Real-time Process |
| S059 | 2015-02-04 | 30-day Notice |
| S058 | 2014-10-31 | 30-day Notice |
| S057 | 2014-09-25 | Normal 180 Day Track |
| S056 | 2014-09-24 | 30-day Notice |
| S055 | 2014-09-19 | 30-day Notice |
| S054 | 2014-07-28 | Normal 180 Day Track |
| S053 | 2014-06-23 | Normal 180 Day Track |
| S052 | 2014-06-23 | 30-day Notice |
| S051 | 2014-05-30 | 30-day Notice |
| S050 | 2013-11-25 | Normal 180 Day Track |
| S049 | 2013-11-07 | Real-time Process |
| S048 | 2013-11-05 | 30-day Notice |
| S047 | 2013-08-15 | Real-time Process |
| S046 | 2013-07-29 | Real-time Process |
| S045 | 2013-07-16 | 30-day Notice |
| S044 | 2013-06-03 | Real-time Process |
| S043 | 2013-04-29 | 30-day Notice |
| S042 | 2013-04-22 | 30-day Notice |
| S041 | 2013-04-03 | Real-time Process |
| S040 | ||
| S039 | 2013-02-05 | Real-time Process |
| S038 | 2013-01-14 | 30-day Notice |
| S037 | 2012-12-21 | Real-time Process |
| S036 | 2012-12-18 | Normal 180 Day Track |
| S035 | 2012-11-19 | Real-time Process |
| S034 | 2012-09-07 | 30-day Notice |
| S033 | 2012-07-02 | Real-time Process |
| S032 | 2012-04-02 | 135 Review Track For 30-day Notice |
| S031 | 2012-03-01 | Normal 180 Day Track |
| S030 | 2012-02-17 | Real-time Process |
| S029 | 2012-02-06 | 30-day Notice |
| S028 | 2011-11-02 | Normal 180 Day Track |
| S027 | 2011-10-03 | Real-time Process |
| S026 | 2011-08-19 | Normal 180 Day Track |
| S025 | 2011-06-23 | 30-day Notice |
| S024 | 2011-06-16 | 135 Review Track For 30-day Notice |
| S023 | 2011-04-11 | Real-time Process |
| S022 | ||
| S021 | 2010-12-13 | Real-time Process |
| S020 | 2010-11-09 | 30-day Notice |
| S019 | 2010-10-28 | Normal 180 Day Track |
| S018 | 2010-08-20 | 30-day Notice |
| S017 | 2010-06-08 | Normal 180 Day Track |
| S016 | 2010-05-28 | Normal 180 Day Track No User Fee |
| S015 | 2010-02-24 | Normal 180 Day Track |
| S014 | 2009-11-25 | Real-time Process |
| S013 | 2009-09-30 | Real-time Process |
| S012 | 2009-09-10 | Real-time Process |
| S011 | 2009-07-08 | Normal 180 Day Track |
| S010 | 2009-02-13 | Real-time Process |
| S009 | 2009-01-26 | Normal 180 Day Track |
| S008 | 2008-11-17 | Normal 180 Day Track |
| S007 | 2008-10-31 | Real-time Process |
| S006 | 2008-09-05 | 30-day Notice |
| S005 | 2008-06-11 | Normal 180 Day Track No User Fee |
| S004 | 2008-06-04 | 135 Review Track For 30-day Notice |
| S003 | 2008-06-02 | Real-time Process |
| S002 | 2008-05-15 | Real-time Process |
| S001 | 2008-05-15 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 04035479093532 | P070008 | 000 |
| 04035479093549 | P070008 | 000 |
| 04035479094157 | P070008 | 000 |
| 04035479094164 | P070008 | 000 |
| 04035479112165 | P070008 | 015 |
| 04035479112172 | P070008 | 015 |
| 04035479143473 | P070008 | 027 |
| 04035479143282 | P070008 | 027 |
| 04035479143275 | P070008 | 027 |
| 04035479143268 | P070008 | 027 |
| 04035479143251 | P070008 | 027 |
| 04035479143244 | P070008 | 027 |
| 04035479143237 | P070008 | 027 |
| 04035479143480 | P070008 | 027 |
| 04035479147563 | P070008 | 076 |
| 04035479147570 | P070008 | 076 |
| 04035479145590 | P070008 | 079 |
| 04035479145613 | P070008 | 079 |
| 04035479138455 | P070008 | 079 |
| 04035479138448 | P070008 | 079 |
| 04035479138431 | P070008 | 079 |
| 04035479138424 | P070008 | 079 |
| 04035479138417 | P070008 | 079 |
| 04035479138400 | P070008 | 079 |
| 04035479148959 | P070008 | 079 |
| 04035479148942 | P070008 | 079 |
| 04035479145606 | P070008 | 079 |
| 04035479148966 | P070008 | 079 |