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 of the post-approval study for the device.
Device | KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18 |
Classification Name | Tester, Pacemaker Electrode Function |
Generic Name | Tester, Pacemaker Electrode Function |
Applicant | BIOTRONIK, INC. |
Date Received | 2003-02-19 |
Decision Date | 2003-07-29 |
PMA | P980023 |
Supplement | S013 |
Product Code | DTA |
Advisory Committee | Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol - Ode/oir |
Expedited Review | No |
Combination Product | No |
Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
Supplement Number | Date | Supplement Type |
---|---|---|
P980023 | Original Filing | |
S118 | 2022-11-30 | Normal 180 Day Track No User Fee |
S117 | 2022-11-23 | 30-day Notice |
S116 | 2022-11-10 | 30-day Notice |
S115 | 2022-09-22 | 30-day Notice |
S114 | 2022-06-17 | 30-day Notice |
S113 | ||
S112 | 2022-02-17 | 30-day Notice |
S111 | ||
S110 | 2021-11-23 | 30-day Notice |
S109 | 2021-09-30 | 30-day Notice |
S108 | ||
S107 | 2021-07-21 | 30-day Notice |
S106 | 2021-06-21 | 30-day Notice |
S105 | 2021-03-16 | Real-time Process |
S104 | 2020-11-23 | 30-day Notice |
S103 | 2020-11-02 | 30-day Notice |
S102 | 2020-08-10 | Real-time Process |
S101 | 2020-03-26 | 30-day Notice |
S100 | ||
S099 | ||
S098 | ||
S097 | 2019-12-31 | 30-day Notice |
S096 | ||
S095 | 2019-09-17 | 30-day Notice |
S094 | 2019-08-15 | Real-time Process |
S093 | 2019-07-01 | Real-time Process |
S092 | 2019-04-23 | 30-day Notice |
S091 | 2019-03-18 | 30-day Notice |
S090 | 2018-12-11 | Normal 180 Day Track No User Fee |
S089 | 2018-11-23 | Real-time Process |
S088 | 2018-11-16 | 30-day Notice |
S087 | ||
S086 | 2018-07-10 | 30-day Notice |
S085 | 2018-06-14 | 135 Review Track For 30-day Notice |
S084 | 2018-01-22 | 30-day Notice |
S083 | 2017-11-20 | 30-day Notice |
S082 | 2017-11-20 | Real-time Process |
S081 | 2017-04-12 | Real-time Process |
S080 | 2017-03-07 | 30-day Notice |
S079 | 2016-11-21 | 30-day Notice |
S078 | 2016-09-23 | 30-day Notice |
S077 | 2016-08-01 | 30-day Notice |
S076 | 2016-06-06 | Normal 180 Day Track |
S075 | 2016-05-24 | Normal 180 Day Track |
S074 | 2015-12-23 | Normal 180 Day Track |
S073 | 2015-08-03 | 30-day Notice |
S072 | 2015-04-16 | Normal 180 Day Track |
S071 | 2015-06-19 | Real-time Process |
S070 | 2015-06-17 | Normal 180 Day Track No User Fee |
S069 | 2015-06-15 | 30-day Notice |
S068 | 2015-05-27 | 30-day Notice |
S067 | 2015-05-22 | 30-day Notice |
S066 | 2015-04-29 | 135 Review Track For 30-day Notice |
S065 | 2015-03-06 | 135 Review Track For 30-day Notice |
S064 | 2015-02-04 | 30-day Notice |
S063 | 2015-01-08 | 30-day Notice |
S062 | 2014-09-24 | 30-day Notice |
S061 | 2014-09-19 | 30-day Notice |
S060 | 2014-07-28 | Normal 180 Day Track |
S059 | 2014-06-23 | 30-day Notice |
S058 | 2014-05-30 | 30-day Notice |
S057 | 2014-01-27 | Normal 180 Day Track |
S056 | 2013-06-14 | Real-time Process |
S055 | 2013-04-29 | 30-day Notice |
S054 | 2013-04-24 | 135 Review Track For 30-day Notice |
S053 | 2013-04-22 | 30-day Notice |
S052 | 2013-04-03 | Real-time Process |
S051 | 2013-01-14 | 30-day Notice |
S050 | 2012-12-21 | Real-time Process |
S049 | 2012-11-14 | Normal 180 Day Track |
S048 | 2012-09-07 | 30-day Notice |
S047 | 2012-08-29 | 30-day Notice |
S046 | 2011-11-14 | Normal 180 Day Track |
S045 | ||
S044 | 2011-04-11 | Real-time Process |
S043 | 2010-12-29 | Real-time Process |
S042 | ||
S041 | 2010-05-28 | Normal 180 Day Track No User Fee |
S040 | 2010-04-13 | 30-day Notice |
S039 | 2010-02-12 | 30-day Notice |
S038 | 2009-08-19 | Normal 180 Day Track |
S037 | 2008-11-20 | Real-time Process |
S036 | 2008-11-17 | Normal 180 Day Track |
S035 | 2008-10-31 | Real-time Process |
S034 | 2008-06-04 | 135 Review Track For 30-day Notice |
S033 | 2008-05-21 | Real-time Process |
S032 | 2008-05-14 | Real-time Process |
S031 | 2008-05-14 | Normal 180 Day Track |
S030 | 2008-01-07 | Real-time Process |
S029 | 2007-07-13 | Normal 180 Day Track |
S028 | 2007-06-25 | 30-day Notice |
S027 | 2006-12-18 | Real-time Process |
S026 | 2006-10-12 | Real-time Process |
S025 | 2006-09-11 | Normal 180 Day Track |
S024 | 2006-06-29 | Real-time Process |
S023 | 2006-06-02 | Real-time Process |
S022 | 2006-04-10 | 135 Review Track For 30-day Notice |
S021 | 2006-03-10 | Real-time Process |
S020 | 2005-09-06 | Normal 180 Day Track |
S019 | 2004-12-19 | Normal 180 Day Track |
S018 | 2004-06-14 | Real-time Process |
S017 | 2004-04-02 | Normal 180 Day Track |
S016 | 2003-09-15 | Real-time Process |
S015 | 2003-07-16 | Normal 180 Day Track No User Fee |
S014 | 2003-03-10 | Normal 180 Day Track |
S013 | 2003-02-19 | Normal 180 Day Track |
S012 | 2003-01-27 | Normal 180 Day Track |
S011 | 2002-11-20 | 30-day Notice |
S010 | 2002-07-22 | Real-time Process |
S009 | 2002-06-04 | Normal 180 Day Track |
S008 | 2002-04-08 | Real-time Process |
S007 | 2002-01-22 | Normal 180 Day Track |
S006 | 2002-02-04 | Real-time Process |
S005 | 2001-06-25 | Normal 180 Day Track |
S004 | 2001-04-27 | Normal 180 Day Track |
S003 | 1999-11-02 | Normal 180 Day Track |
S002 | 1999-06-01 | Real-time Process |
S001 | 1999-02-22 | Real-time Process |