Approval for the smartview 2. 02 ug2 software as well as associated labeling and operator manual updates. The software modifications are intended to make minor software corrections (manager, ovation) and to include a downloadable ram patch (symphony/ rhapsody).
| Device | ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2007-08-29 |
| Decision Date | 2007-11-13 |
| PMA | P980049 |
| Supplement | S028 |
| Product Code | MRM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980049 | | Original Filing |
| S143 |
2022-07-20 |
Real-time Process |
| S142 |
2021-01-08 |
Real-time Process |
| S141 | | |
| S140 |
2020-09-24 |
30-day Notice |
| S139 | | |
| S138 |
2020-07-13 |
30-day Notice |
| S137 | | |
| S136 |
2020-02-10 |
30-day Notice |
| S135 | | |
| S134 |
2019-02-05 |
30-day Notice |
| S133 |
2018-12-20 |
Real-time Process |
| S132 |
2018-11-13 |
30-day Notice |
| S131 |
2018-04-19 |
30-day Notice |
| S130 |
2018-03-29 |
30-day Notice |
| S129 |
2018-02-26 |
30-day Notice |
| S128 |
2018-01-03 |
Real-time Process |
| S127 |
2018-01-03 |
30-day Notice |
| S126 |
2017-07-07 |
30-day Notice |
| S125 |
2017-05-22 |
Real-time Process |
| S124 |
2017-02-21 |
30-day Notice |
| S123 |
2016-12-19 |
Normal 180 Day Track |
| S122 |
2016-08-23 |
30-day Notice |
| S121 |
2016-08-23 |
30-day Notice |
| S120 |
2016-08-23 |
30-day Notice |
| S119 |
2016-08-09 |
Real-time Process |
| S118 |
2016-07-26 |
Real-time Process |
| S117 |
2016-07-21 |
Real-time Process |
| S116 |
2016-07-14 |
30-day Notice |
| S115 |
2016-07-13 |
30-day Notice |
| S114 |
2015-11-17 |
135 Review Track For 30-day Notice |
| S113 |
2015-10-20 |
Normal 180 Day Track |
| S112 |
2015-07-07 |
30-day Notice |
| S111 |
2015-07-02 |
30-day Notice |
| S110 |
2015-07-01 |
30-day Notice |
| S109 |
2015-03-30 |
Normal 180 Day Track |
| S108 |
2015-02-24 |
30-day Notice |
| S107 |
2015-02-19 |
30-day Notice |
| S106 |
2015-02-18 |
30-day Notice |
| S105 |
2015-02-11 |
Normal 180 Day Track |
| S104 |
2014-11-21 |
30-day Notice |
| S103 |
2014-10-01 |
Normal 180 Day Track No User Fee |
| S102 |
2014-09-15 |
Real-time Process |
| S101 |
2014-08-05 |
30-day Notice |
| S100 |
2014-06-20 |
30-day Notice |
| S099 |
2014-05-15 |
Normal 180 Day Track |
| S098 |
2014-04-24 |
Real-time Process |
| S097 |
2014-04-23 |
Real-time Process |
| S096 |
2014-04-10 |
30-day Notice |
| S095 |
2014-03-24 |
30-day Notice |
| S094 |
2014-03-18 |
Real-time Process |
| S093 |
2014-02-12 |
Real-time Process |
| S092 |
2014-01-29 |
30-day Notice |
| S091 |
2014-01-29 |
30-day Notice |
| S090 |
2014-01-10 |
Real-time Process |
| S089 |
2013-10-31 |
30-day Notice |
| S088 |
2013-10-17 |
30-day Notice |
| S087 |
2013-09-11 |
30-day Notice |
| S086 |
2013-09-11 |
30-day Notice |
| S085 |
2013-08-21 |
Normal 180 Day Track |
| S084 | | |
| S083 |
2013-07-15 |
30-day Notice |
| S082 |
2013-04-10 |
30-day Notice |
| S081 |
2013-02-25 |
30-day Notice |
| S080 |
2013-02-15 |
Real-time Process |
| S079 |
2013-02-11 |
30-day Notice |
| S078 |
2012-12-21 |
30-day Notice |
| S077 |
2012-07-31 |
30-day Notice |
| S076 |
2012-07-06 |
30-day Notice |
| S075 |
2012-07-05 |
30-day Notice |
| S074 |
2012-05-16 |
30-day Notice |
| S073 |
2012-05-16 |
30-day Notice |
| S072 |
2012-03-23 |
30-day Notice |
| S071 |
2012-03-13 |
Normal 180 Day Track |
| S070 |
2012-01-27 |
30-day Notice |
| S069 |
2012-01-05 |
30-day Notice |
| S068 |
2011-12-12 |
30-day Notice |
| S067 |
2011-11-10 |
30-day Notice |
| S066 |
2011-10-31 |
30-day Notice |
| S065 |
2011-09-01 |
Normal 180 Day Track |
| S064 |
2011-06-06 |
30-day Notice |
| S063 |
2011-02-28 |
30-day Notice |
| S062 |
2010-12-16 |
Real-time Process |
| S061 |
2010-11-29 |
Normal 180 Day Track No User Fee |
| S060 |
2010-08-12 |
Real-time Process |
| S059 |
2010-06-28 |
Normal 180 Day Track |
| S058 |
2010-06-04 |
30-day Notice |
| S057 |
2010-05-17 |
Real-time Process |
| S056 |
2010-04-26 |
30-day Notice |
| S055 |
2010-03-23 |
30-day Notice |
| S054 |
2010-02-12 |
30-day Notice |
| S053 |
2010-02-04 |
135 Review Track For 30-day Notice |
| S052 | | |
| S051 |
2009-11-16 |
30-day Notice |
| S050 |
2009-09-24 |
Normal 180 Day Track |
| S049 |
2009-06-16 |
Special (immediate Track) |
| S048 |
2009-04-09 |
30-day Notice |
| S047 |
2009-03-31 |
30-day Notice |
| S046 |
2009-03-04 |
30-day Notice |
| S045 |
2009-01-28 |
30-day Notice |
| S044 |
2008-11-12 |
Real-time Process |
| S043 |
2008-11-10 |
30-day Notice |
| S042 |
2008-09-15 |
30-day Notice |
| S041 |
2008-08-21 |
Real-time Process |
| S040 |
2008-08-13 |
Normal 180 Day Track |
| S039 |
2008-08-06 |
Real-time Process |
| S038 |
2008-06-23 |
Special (immediate Track) |
| S037 |
2008-06-10 |
Real-time Process |
| S036 |
2008-03-13 |
135 Review Track For 30-day Notice |
| S035 |
2008-03-05 |
Real-time Process |
| S034 | | |
| S033 |
2008-02-15 |
30-day Notice |
| S032 |
2008-02-15 |
30-day Notice |
| S031 |
2008-02-15 |
30-day Notice |
| S030 |
2008-02-14 |
30-day Notice |
| S029 |
2008-02-11 |
135 Review Track For 30-day Notice |
| S028 |
2007-08-29 |
Real-time Process |
| S027 |
2007-05-25 |
Normal 180 Day Track No User Fee |
| S026 |
2007-04-19 |
30-day Notice |
| S025 |
2007-01-24 |
Normal 180 Day Track |
| S024 |
2006-10-16 |
Normal 180 Day Track |
| S023 |
2006-07-11 |
Real-time Process |
| S022 |
2006-01-17 |
Real-time Process |
| S021 |
2005-05-16 |
Normal 180 Day Track |
| S020 |
2005-04-29 |
Normal 180 Day Track |
| S019 |
2005-04-13 |
30-day Notice |
| S018 |
2005-01-31 |
30-day Notice |
| S017 |
2004-09-15 |
Real-time Process |
| S016 |
2004-08-18 |
135 Review Track For 30-day Notice |
| S015 |
2004-03-03 |
Real-time Process |
| S014 |
2004-02-23 |
Real-time Process |
| S013 |
2004-02-20 |
Real-time Process |
| S012 |
2004-02-17 |
Special (immediate Track) |
| S011 |
2003-09-23 |
Real-time Process |
| S010 |
2003-09-11 |
Real-time Process |
| S009 |
2003-05-22 |
Real-time Process |
| S008 |
2002-04-15 |
Normal 180 Day Track |
| S007 |
2001-11-30 |
Real-time Process |
| S006 |
2001-11-28 |
Real-time Process |
| S005 |
2001-05-17 |
Real-time Process |
| S004 |
2001-01-16 |
Real-time Process |
| S003 |
2000-11-21 |
Real-time Process |
| S002 |
2000-07-06 |
Normal 180 Day Track |
| S001 |
1999-10-15 |
Normal 180 Day Track |
NIH GUDID Devices