Approval for the ovatio crt-d system. The ovatio crt-d is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized nyha functional class iii and iv patients with left ventricular ejection fraction of 35% or less, and a qrs duration of 150 ms or longer. Situs otw lv lead is designed to pace the left ventricle through a coronary vein. It is intended to be used in conjunction with ela medical cardiac synchronization therapy pulse generators.
| Device | OVATIO CRT SYSTEM |
| Classification Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Generic Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Applicant | MicroPort CRM USA Inc. |
| Date Received | 2006-10-02 |
| Decision Date | 2008-05-15 |
| Notice Date | 2008-07-28 |
| PMA | P060027 |
| Supplement | S |
| Product Code | NIK |
| Docket Number | 08M-0426 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| 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 |
|---|
| P060027 | | Original Filing |
| S105 |
2020-09-30 |
Normal 180 Day Track |
| S104 |
2020-09-24 |
30-day Notice |
| S103 |
2020-07-13 |
30-day Notice |
| S102 |
2020-02-10 |
30-day Notice |
| S101 | | |
| S100 |
2019-11-15 |
30-day Notice |
| S099 |
2019-02-05 |
30-day Notice |
| S098 |
2018-12-20 |
Real-time Process |
| S097 |
2018-11-13 |
30-day Notice |
| S096 |
2018-04-19 |
30-day Notice |
| S095 |
2018-03-29 |
30-day Notice |
| S094 |
2018-02-26 |
30-day Notice |
| S093 |
2018-01-03 |
Real-time Process |
| S092 |
2018-01-03 |
30-day Notice |
| S091 |
2017-07-07 |
30-day Notice |
| S090 |
2017-05-22 |
Real-time Process |
| S089 |
2017-02-21 |
30-day Notice |
| S088 |
2016-12-19 |
Normal 180 Day Track |
| S087 |
2016-08-23 |
30-day Notice |
| S086 |
2016-08-23 |
30-day Notice |
| S085 |
2016-08-23 |
30-day Notice |
| S084 |
2016-08-09 |
Real-time Process |
| S083 |
2016-07-21 |
Real-time Process |
| S082 |
2016-07-14 |
30-day Notice |
| S081 |
2016-07-13 |
30-day Notice |
| S080 |
2015-11-17 |
135 Review Track For 30-day Notice |
| S079 |
2015-10-20 |
Normal 180 Day Track |
| S078 |
2015-07-07 |
30-day Notice |
| S077 |
2015-07-02 |
30-day Notice |
| S076 |
2015-07-01 |
30-day Notice |
| S075 |
2015-02-24 |
30-day Notice |
| S074 |
2015-02-19 |
30-day Notice |
| S073 |
2015-02-18 |
30-day Notice |
| S072 |
2015-02-11 |
Normal 180 Day Track |
| S071 |
2014-11-21 |
30-day Notice |
| S070 |
2014-10-01 |
Normal 180 Day Track No User Fee |
| S069 |
2014-09-15 |
Real-time Process |
| S068 |
2014-08-06 |
30-day Notice |
| S067 |
2014-06-20 |
30-day Notice |
| S066 |
2014-05-15 |
Normal 180 Day Track |
| S065 |
2014-04-24 |
Real-time Process |
| S064 |
2014-04-23 |
Real-time Process |
| S063 |
2014-04-10 |
30-day Notice |
| S062 |
2014-03-24 |
30-day Notice |
| S061 |
2014-03-18 |
Real-time Process |
| S060 |
2014-02-12 |
Real-time Process |
| S059 |
2014-01-29 |
30-day Notice |
| S058 |
2014-01-29 |
30-day Notice |
| S057 |
2013-10-31 |
30-day Notice |
| S056 |
2013-10-17 |
30-day Notice |
| S055 |
2013-09-11 |
30-day Notice |
| S054 |
2013-09-11 |
30-day Notice |
| S053 |
2013-08-21 |
Normal 180 Day Track |
| S052 | | |
| S051 |
2013-07-15 |
30-day Notice |
| S050 |
2013-04-10 |
30-day Notice |
| S049 |
2013-02-25 |
30-day Notice |
| S048 |
2013-02-15 |
Real-time Process |
| S047 |
2013-02-11 |
30-day Notice |
| S046 |
2012-12-21 |
30-day Notice |
| S045 |
2012-07-31 |
30-day Notice |
| S044 |
2012-07-06 |
30-day Notice |
| S043 |
2012-07-05 |
30-day Notice |
| S042 | | |
| S041 |
2012-05-16 |
30-day Notice |
| S040 |
2012-05-16 |
30-day Notice |
| S039 |
2012-03-23 |
30-day Notice |
| S038 |
2012-03-13 |
Normal 180 Day Track |
| S037 |
2012-01-27 |
30-day Notice |
| S036 |
2012-01-05 |
30-day Notice |
| S035 |
2011-12-12 |
30-day Notice |
| S034 |
2011-11-10 |
30-day Notice |
| S033 |
2011-10-31 |
30-day Notice |
| S032 |
2011-09-01 |
Normal 180 Day Track |
| S031 |
2011-06-06 |
30-day Notice |
| S030 |
2011-02-28 |
30-day Notice |
| S029 |
2010-12-16 |
Real-time Process |
| S028 |
2010-08-12 |
Real-time Process |
| S027 |
2010-07-16 |
Normal 180 Day Track No User Fee |
| S026 |
2010-06-28 |
Normal 180 Day Track |
| S025 |
2010-06-04 |
30-day Notice |
| S024 |
2010-05-17 |
Real-time Process |
| S023 |
2010-04-26 |
30-day Notice |
| S022 |
2010-03-30 |
30-day Notice |
| S021 |
2010-02-12 |
30-day Notice |
| S020 |
2010-02-05 |
30-day Notice |
| S019 |
2010-02-04 |
135 Review Track For 30-day Notice |
| S018 | | |
| S017 |
2010-01-06 |
30-day Notice |
| S016 |
2009-11-16 |
30-day Notice |
| S015 |
2009-09-24 |
Normal 180 Day Track |
| S014 |
2009-04-09 |
30-day Notice |
| S013 |
2009-03-31 |
30-day Notice |
| S012 |
2009-03-04 |
30-day Notice |
| S011 |
2009-02-20 |
30-day Notice |
| S010 |
2009-01-28 |
30-day Notice |
| S009 |
2008-12-17 |
Normal 180 Day Track No User Fee |
| S008 |
2008-11-12 |
Real-time Process |
| S007 |
2008-11-10 |
135 Review Track For 30-day Notice |
| S006 |
2008-09-15 |
30-day Notice |
| S005 |
2008-08-21 |
Real-time Process |
| S004 |
2008-08-13 |
Normal 180 Day Track |
| S003 |
2008-06-23 |
Special (immediate Track) |
| S002 |
2008-06-13 |
Normal 180 Day Track No User Fee |
| S001 |
2008-06-10 |
Real-time Process |
NIH GUDID Devices