Approval for an implantable cardioverter defibrillator (icd) that combines features of the alto 2 dr 624, alto 2 vr 625 icds, and symphony 2550 pacemaker, including reduced size, modified shock circuitry and other changes. The device will be marketed under the trade name ovatio dr model 6550 and ovatio vr model 6250 icds, elaview 1. 32 ug2 programming software and cpr3 programming head with hso 2. 76 software and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted.
| Device | OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD |
| Classification Name | Defibrillator, Implantable, Dual-chamber |
| Generic Name | Defibrillator, Implantable, Dual-chamber |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2005-04-29 |
| Decision Date | 2006-04-28 |
| PMA | P980049 |
| Supplement | S020 |
| Product Code | MRM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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