Approval for the paradym model 8750 crt-d with smartview 2. 16 ug2 programmer software. The device 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.
| Device | PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE |
| 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 | 2009-02-20 |
| Decision Date | 2009-10-27 |
| PMA | P060027 |
| Supplement | S011 |
| Product Code | NIK |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| 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 |
|---|
| 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