Addition fo an eto sterilizer at the tolochenaz, switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the eto sterilizer is not applicable to the following devices: consulta, maximo ii, secura dr/vr family, and maximo ii ddr/vr family.
| Device | GEM & GEM II VR |
| Classification Name | Implantable Cardioverter Defibrillator (non-crt) |
| Generic Name | Implantable Cardioverter Defibrillator (non-crt) |
| Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
| Date Received | 2008-08-11 |
| Decision Date | 2008-09-10 |
| PMA | P900061 |
| Supplement | S078 |
| 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 |
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