Approval for an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.
| Device | ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2013-05-17 |
| Decision Date | 2013-07-23 |
| PMA | P900061 |
| Supplement | S122 |
| Product Code | LWS |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112 |
Supplemental Filings
| 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 |
NIH GUDID Devices