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 | ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT8200 Coral Sea Street N.e.mounds View, MN 55112 PMA NumberP900061 Supplement NumberS169 Date Received05/20/2022 Decision Date06/01/2022 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-06-01 |
| PMA | P900061 |
| Supplement | S169 |
| Product Code | LWS |
| 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 PMA NumberP900061 Supplement NumberS169 Date Received05/20/2022 Decision Date06/01/2022 Product Code LWS Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Update The FACTORYWorks Manufacturing Execution System To Release 9.10 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900061 | Original Filing | |
| S169 | 2022-05-20 | 30-day Notice |
| S168 | 2022-04-14 | 30-day Notice |
| S167 | 2021-11-18 | 30-day Notice |
| S166 | ||
| S165 | 2021-08-09 | 30-day Notice |
| S164 | 2021-02-05 | 30-day Notice |
| S163 | 2020-12-01 | 30-day Notice |
| S162 | 2020-11-24 | 30-day Notice |
| S161 | 2020-10-23 | 30-day Notice |
| S160 | 2020-07-09 | 30-day Notice |
| S159 | 2020-06-26 | 30-day Notice |
| S158 | 2020-03-23 | Real-time Process |
| S157 | 2020-02-20 | 30-day Notice |
| S156 | 2019-11-18 | 30-day Notice |
| S155 | 2019-09-16 | 30-day Notice |
| S154 | 2019-06-10 | 30-day Notice |
| S153 | 2019-04-23 | 30-day Notice |
| S152 | 2019-02-28 | 30-day Notice |
| S151 | 2018-10-23 | 30-day Notice |
| S150 | 2018-10-18 | 30-day Notice |
| S149 | 2018-05-15 | 30-day Notice |
| S148 | 2018-02-22 | 30-day Notice |
| S147 | 2017-11-20 | 30-day Notice |
| S146 | 2017-06-07 | 30-day Notice |
| S145 | 2017-01-17 | 30-day Notice |
| S144 | 2016-11-14 | 30-day Notice |
| S143 | 2016-10-05 | 30-day Notice |
| S142 | 2016-09-22 | 30-day Notice |
| S141 | 2016-09-06 | 30-day Notice |
| S140 | 2016-06-24 | 30-day Notice |
| S139 | 2015-12-28 | 30-day Notice |
| S138 | 2015-12-28 | 30-day Notice |
| S137 | 2015-09-10 | 30-day Notice |
| S136 | 2015-07-02 | Real-time Process |
| S135 | 2015-04-17 | 30-day Notice |
| S134 | 2015-04-14 | Real-time Process |
| S133 | 2014-12-22 | Normal 180 Day Track |
| S132 | 2014-10-15 | 30-day Notice |
| S131 | 2014-08-27 | 30-day Notice |
| S130 | 2014-07-24 | 30-day Notice |
| S129 | 2014-07-02 | Real-time Process |
| S128 | 2014-02-27 | 30-day Notice |
| S127 | 2014-01-29 | 30-day Notice |
| S126 | 2013-12-19 | 30-day Notice |
| S125 | 2013-12-17 | 30-day Notice |
| S124 | 2013-10-30 | 30-day Notice |
| S123 | 2013-10-24 | 30-day Notice |
| S122 | 2013-05-17 | Real-time Process |
| S121 | 2013-04-18 | Real-time Process |
| S120 | 2013-04-10 | Normal 180 Day Track No User Fee |
| S119 | 2013-03-22 | 30-day Notice |
| S118 | 2012-11-21 | 30-day Notice |
| S117 | 2012-11-13 | 30-day Notice |
| S116 | ||
| S115 | 2012-08-03 | 30-day Notice |
| S114 | 2012-04-04 | Real-time Process |
| S113 | 2012-03-26 | Real-time Process |
| S112 | 2012-02-29 | 30-day Notice |
| S111 | 2011-11-21 | Normal 180 Day Track |
| S110 | 2011-09-19 | Real-time Process |
| S109 | 2011-07-28 | 135 Review Track For 30-day Notice |
| S108 | 2011-07-18 | 30-day Notice |
| S107 | 2011-07-08 | 30-day Notice |
| S106 | 2011-07-06 | 30-day Notice |
| S105 | 2011-06-28 | 30-day Notice |
| S104 | 2011-06-08 | 30-day Notice |
| S103 | 2011-05-13 | 30-day Notice |
| S102 | 2011-04-26 | 30-day Notice |
| S101 | 2011-04-12 | 30-day Notice |
| S100 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S099 | 2011-02-28 | 30-day Notice |
| S098 | 2011-01-04 | Normal 180 Day Track |
| S097 | 2010-11-12 | 30-day Notice |
| S096 | 2010-10-26 | 30-day Notice |
| S095 | ||
| S094 | 2010-07-15 | 30-day Notice |
| S093 | 2010-07-15 | 30-day Notice |
| S092 | 2010-07-15 | 30-day Notice |
| S091 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S090 | 2010-06-23 | 30-day Notice |
| S089 | 2010-05-20 | Real-time Process |
| S088 | 2010-03-29 | 30-day Notice |
| S087 | 2010-03-01 | Real-time Process |
| S086 | 2010-01-19 | 30-day Notice |
| S085 | 2010-01-15 | Real-time Process |
| S084 | 2009-06-17 | Real-time Process |
| S083 | 2009-03-02 | Normal 180 Day Track |
| S082 | 2008-12-22 | Normal 180 Day Track No User Fee |
| S081 | 2008-12-11 | 30-day Notice |
| S080 | 2008-11-03 | 30-day Notice |
| S079 | 2008-10-17 | Real-time Process |
| S078 | 2008-08-11 | 30-day Notice |
| S077 | 2008-07-28 | Normal 180 Day Track |
| S076 | 2008-06-17 | 30-day Notice |
| S075 | 2008-04-14 | 30-day Notice |
| S074 | 2007-09-28 | Normal 180 Day Track |
| S073 | 2007-08-23 | Special (immediate Track) |
| S072 | 2007-03-09 | Real-time Process |
| S071 | 2006-12-01 | Normal 180 Day Track No User Fee |
| S070 | 2006-11-20 | 30-day Notice |
| S069 | 2006-10-30 | Real-time Process |
| S068 | 2006-10-30 | Normal 180 Day Track No User Fee |
| S067 | 2006-10-17 | 30-day Notice |
| S066 | 2006-06-28 | Special (immediate Track) |
| S065 | 2006-05-10 | 135 Review Track For 30-day Notice |
| S064 | 2006-04-10 | Real-time Process |
| S063 | 2006-02-21 | Real-time Process |
| S062 | 2006-02-14 | Real-time Process |
| S061 | 2006-02-01 | Special (immediate Track) |
| S060 | 2005-12-09 | Normal 180 Day Track |
| S059 | 2005-12-08 | Real-time Process |
| S058 | ||
| S057 | 2005-09-16 | Real-time Process |
| S056 | 2002-03-27 | Real-time Process |
| S055 | 2003-01-27 | Real-time Process |
| S054 | 2002-12-18 | Normal 180 Day Track No User Fee |
| S053 | 2002-12-03 | Normal 180 Day Track |
| S052 | 2002-05-30 | Real-time Process |
| S051 | 2001-11-05 | Special (immediate Track) |
| S050 | 2001-10-26 | Special (immediate Track) |
| S049 | 2001-09-26 | Normal 180 Day Track |
| S048 | 2001-09-24 | 30-day Notice |
| S047 | 2001-09-07 | Real-time Process |
| S046 | 2001-07-25 | Real-time Process |
| S045 | 2001-07-17 | 30-day Notice |
| S044 | 2001-04-17 | Real-time Process |
| S043 | 2001-02-22 | Real-time Process |
| S042 | 2001-02-05 | Normal 180 Day Track |
| S041 | 1999-12-17 | Normal 180 Day Track |
| S040 | ||
| S039 | 1999-07-26 | Normal 180 Day Track |
| S038 | 1999-05-26 | Real-time Process |
| S037 | 1999-03-31 | Normal 180 Day Track |
| S036 | 1999-03-08 | Normal 180 Day Track |
| S035 | 1998-02-17 | Normal 180 Day Track |
| S034 | 1997-11-17 | Normal 180 Day Track |
| S033 | 1997-05-19 | Normal 180 Day Track |
| S032 | 1997-05-05 | Normal 180 Day Track |
| S031 | 1997-02-18 | Normal 180 Day Track |
| S030 | 1996-12-23 | Normal 180 Day Track |
| S029 | 1996-11-18 | Normal 180 Day Track |
| S028 | 1996-07-15 | Normal 180 Day Track |
| S027 | 1996-07-15 | Normal 180 Day Track |
| S026 | ||
| S025 | ||
| S024 | 1996-04-24 | Normal 180 Day Track |
| S023 | 1996-04-03 | Normal 180 Day Track |
| S022 | 1996-02-15 | Normal 180 Day Track |
| S021 | 1995-11-02 | Normal 180 Day Track |
| S020 | 1995-08-25 | Normal 180 Day Track |
| S019 | 1995-08-14 | Normal 180 Day Track |
| S018 | 1995-08-10 | Normal 180 Day Track |
| S017 | 1995-08-01 | Normal 180 Day Track |
| S016 | 1995-07-19 | Normal 180 Day Track |
| S015 | 1995-07-18 | Normal 180 Day Track |
| S014 | 1995-07-03 | Normal 180 Day Track |
| S013 | 1995-06-26 | Normal 180 Day Track |
| S012 | 1995-05-30 | Normal 180 Day Track |
| S011 | 1995-05-30 | Normal 180 Day Track |
| S010 | 1995-04-11 | Special (immediate Track) |
| S009 | 1994-12-19 | Normal 180 Day Track |
| S008 | 1994-10-18 | Normal 180 Day Track |
| S007 | 1994-05-02 | Normal 180 Day Track |
| S006 | 1994-04-25 | Normal 180 Day Track |
| S005 | 1994-04-01 | Normal 180 Day Track |
| S004 | 1994-03-25 | Normal 180 Day Track |
| S003 | 1993-09-09 | Normal 180 Day Track |
| S002 | 1993-04-09 | Normal 180 Day Track |
| S001 | 1993-02-26 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00613994534583 | P900061 | 000 |
| 00681490148733 | P900061 | 001 |
| 00681490148818 | P900061 | 001 |
| 00681490148771 | P900061 | 002 |
| 00681490132039 | P900061 | 016 |
| 00681490149747 | P900061 | 031 |
| 20613994647812 | P900061 | 035 |
| 00613994520890 | P900061 | 082 |
| 00613994520937 | P900061 | 082 |
| 00763000059354 | P900061 | 122 |