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 HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T |
| Classification Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Generic Name | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p) |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-06-14 |
| Decision Date | 2019-02-12 |
| PMA | P070008 |
| Supplement | S094 |
| Product Code | NKE |
| 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 | Yes |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
Supplemental Filings
| 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 |
NIH GUDID Devices