This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have expierienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (vt).
Device | DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Classification Name | Defibrillator, Implantable, Dual-chamber |
Generic Name | Defibrillator, Implantable, Dual-chamber |
Applicant | MicroPort CRM USA Inc. |
Date Received | 1998-12-18 |
Decision Date | 1999-09-15 |
PMA | P980049 |
Supplement | S |
Product Code | MRM |
Docket Number | 00M-0915 |
Advisory Committee | Cardiovascular |
Expedited Review | No |
Combination Product | No |
Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling |
Post-Approval Study: | Show Report Schedule and Study Progress |
Approval Order: | Approval Order |
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