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.
Implementation of an updated version of the statistical process control (spc) software system across multiple manufacturing locations and vertically integrated suppliers.
| Device | CAPSURE/STERX TIP PACING/CAPSURE Z/SP NOVUS/VITATRON IMPULSE/II/VITATRON EXCELLENCE S+/VITATRON EXCELLENCE SS+ LEAD DRUG |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2010-10-26 |
| Decision Date | 2010-11-23 |
| PMA | P850089 |
| Supplement | S071 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850089 | Original Filing | |
| S163 | 2022-11-16 | 30-day Notice |
| S162 | 2022-05-20 | 30-day Notice |
| S161 | 2022-04-14 | 30-day Notice |
| S160 | 2022-01-13 | 30-day Notice |
| S159 | 2021-11-18 | 30-day Notice |
| S158 | ||
| S157 | 2021-08-13 | 30-day Notice |
| S156 | 2021-08-09 | 30-day Notice |
| S155 | 2021-06-15 | 30-day Notice |
| S154 | 2021-02-05 | 30-day Notice |
| S153 | 2021-01-12 | 30-day Notice |
| S152 | 2020-12-01 | 30-day Notice |
| S151 | 2020-11-24 | 30-day Notice |
| S150 | 2020-10-23 | 30-day Notice |
| S149 | 2020-07-09 | 30-day Notice |
| S148 | 2020-06-26 | 30-day Notice |
| S147 | 2020-03-23 | Real-time Process |
| S146 | 2020-02-20 | 30-day Notice |
| S145 | 2019-11-18 | 30-day Notice |
| S144 | 2019-09-16 | 30-day Notice |
| S143 | 2019-07-01 | 30-day Notice |
| S142 | 2019-06-20 | 30-day Notice |
| S141 | 2019-06-10 | 30-day Notice |
| S140 | 2019-02-28 | 30-day Notice |
| S139 | 2018-11-21 | 30-day Notice |
| S138 | 2018-10-23 | 30-day Notice |
| S137 | 2018-10-18 | 30-day Notice |
| S136 | 2018-09-26 | 30-day Notice |
| S135 | 2018-06-20 | 30-day Notice |
| S134 | 2018-06-01 | 30-day Notice |
| S133 | 2018-05-15 | 30-day Notice |
| S132 | 2018-04-09 | 30-day Notice |
| S131 | 2018-03-28 | 30-day Notice |
| S130 | 2018-02-22 | 30-day Notice |
| S129 | 2017-11-20 | 30-day Notice |
| S128 | 2017-10-20 | 30-day Notice |
| S127 | 2017-08-07 | 30-day Notice |
| S126 | 2017-06-28 | 30-day Notice |
| S125 | 2017-06-23 | 30-day Notice |
| S124 | 2017-06-07 | 30-day Notice |
| S123 | 2017-01-17 | 30-day Notice |
| S122 | 2016-11-28 | 30-day Notice |
| S121 | 2016-11-14 | 30-day Notice |
| S120 | 2016-10-05 | 30-day Notice |
| S119 | 2016-09-02 | 30-day Notice |
| S118 | 2016-06-24 | 30-day Notice |
| S117 | 2016-03-17 | 30-day Notice |
| S116 | 2015-12-28 | 30-day Notice |
| S115 | 2015-12-22 | 30-day Notice |
| S114 | 2015-04-17 | 30-day Notice |
| S113 | 2015-02-09 | 30-day Notice |
| S112 | 2014-09-29 | 30-day Notice |
| S111 | 2014-08-27 | 30-day Notice |
| S110 | 2014-08-08 | 30-day Notice |
| S109 | 2014-07-24 | 30-day Notice |
| S108 | 2014-07-14 | 30-day Notice |
| S107 | 2014-02-27 | 30-day Notice |
| S106 | 2014-01-29 | 30-day Notice |
| S105 | 2013-12-24 | 30-day Notice |
| S104 | 2013-12-19 | 30-day Notice |
| S103 | 2013-10-30 | 30-day Notice |
| S102 | 2013-10-24 | 30-day Notice |
| S101 | 2013-09-30 | 30-day Notice |
| S100 | 2013-09-17 | 30-day Notice |
| S099 | 2013-05-21 | 30-day Notice |
| S098 | 2013-05-17 | Real-time Process |
| S097 | 2013-04-30 | 30-day Notice |
| S096 | ||
| S095 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S094 | 2013-03-22 | 30-day Notice |
| S093 | 2013-03-20 | 30-day Notice |
| S092 | 2012-12-10 | 30-day Notice |
| S091 | 2012-11-21 | 30-day Notice |
| S090 | 2012-09-28 | 30-day Notice |
| S089 | 2012-08-03 | 30-day Notice |
| S088 | 2012-06-11 | 30-day Notice |
| S087 | 2012-02-29 | 30-day Notice |
| S086 | 2011-11-25 | 30-day Notice |
| S085 | 2011-11-21 | Normal 180 Day Track |
| S084 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S083 | 2011-07-18 | 30-day Notice |
| S082 | 2011-07-08 | 30-day Notice |
| S081 | 2011-06-28 | 30-day Notice |
| S080 | 2011-06-27 | 30-day Notice |
| S079 | 2011-06-08 | 30-day Notice |
| S078 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S077 | 2011-05-13 | 30-day Notice |
| S076 | 2011-04-26 | 30-day Notice |
| S075 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S074 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S073 | 2011-02-28 | 30-day Notice |
| S072 | 2010-11-12 | 30-day Notice |
| S071 | 2010-10-26 | 30-day Notice |
| S070 | 2010-09-29 | 30-day Notice |
| S069 | 2010-07-15 | 30-day Notice |
| S068 | 2010-07-15 | 30-day Notice |
| S067 | 2010-07-15 | 30-day Notice |
| S066 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S065 | 2010-03-29 | 30-day Notice |
| S064 | 2010-01-19 | 30-day Notice |
| S063 | 2010-01-15 | Real-time Process |
| S062 | 2009-10-08 | Real-time Process |
| S061 | 2009-02-05 | 30-day Notice |
| S060 | 2008-12-11 | 30-day Notice |
| S059 | ||
| S058 | 2008-03-24 | 30-day Notice |
| S057 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S056 | 2007-06-27 | 30-day Notice |
| S055 | 2007-05-18 | 30-day Notice |
| S054 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S053 | 2004-03-01 | 135 Review Track For 30-day Notice |
| S052 | 2003-03-04 | 30-day Notice |
| S051 | 2002-12-24 | Real-time Process |
| S050 | 2001-11-14 | Real-time Process |
| S049 | 2001-11-05 | Special (immediate Track) |
| S048 | ||
| S047 | 2001-07-17 | 30-day Notice |
| S046 | 2001-05-21 | Real-time Process |
| S045 | 2000-12-07 | Real-time Process |
| S044 | 2000-01-11 | 30-day Notice |
| S043 | 2000-01-05 | 30-day Notice |
| S042 | 1999-07-09 | Real-time Process |
| S041 | 1999-05-03 | Special (immediate Track) |
| S040 | 1998-10-01 | Real-time Process |
| S039 | 1998-04-20 | |
| S038 | 1997-11-03 | Normal 180 Day Track |
| S037 | 1997-10-10 | Real-time Process |
| S036 | 1996-11-20 | Normal 180 Day Track |
| S035 | 1996-05-08 | Normal 180 Day Track |
| S034 | 1996-05-02 | Normal 180 Day Track |
| S033 | 1995-04-06 | Normal 180 Day Track |
| S032 | 1995-01-30 | Normal 180 Day Track |
| S031 | 1994-09-08 | Normal 180 Day Track |
| S030 | 1994-08-08 | Normal 180 Day Track |
| S029 | 1994-06-01 | Normal 180 Day Track |
| S028 | 1993-08-06 | Normal 180 Day Track |
| S027 | 1993-03-29 | Normal 180 Day Track |
| S026 | 1992-12-24 | Normal 180 Day Track |
| S025 | ||
| S024 | 1992-06-15 | Normal 180 Day Track |
| S023 | 1992-03-30 | Normal 180 Day Track |
| S022 | ||
| S021 | ||
| S020 | 1992-01-27 | Special (immediate Track) |
| S019 | ||
| S018 | 1991-10-03 | Normal 180 Day Track |
| S017 | 1991-07-29 | Normal 180 Day Track |
| S016 | 1991-05-16 | Normal 180 Day Track |
| S015 | 1990-08-20 | Normal 180 Day Track |
| S014 | 1990-05-15 | Normal 180 Day Track |
| S013 | 1990-04-18 | Normal 180 Day Track |
| S012 | 1990-03-12 | Normal 180 Day Track |
| S011 | 1989-03-02 | Normal 180 Day Track |
| S010 | 1989-02-23 | Normal 180 Day Track |
| S009 | 1988-01-03 | Normal 180 Day Track |
| S008 | 1988-10-21 | Normal 180 Day Track |
| S007 | 1988-03-08 | Normal 180 Day Track |
| S006 | 1988-02-25 | Normal 180 Day Track |
| S005 | 1987-07-08 | Normal 180 Day Track |
| S004 | 1987-06-23 | Normal 180 Day Track |
| S003 | 1986-09-25 | Normal 180 Day Track |
| S002 | 1986-09-11 | Normal 180 Day Track |
| S001 | 1986-08-28 | Normal 180 Day Track |