Approval for the paradym vr model 8250 and dr model 8550 with smartview 2. 18ug1 programmer software and the paradym crt-d model 8750 with hardware andmanufacturing changes and labeling and programmer software changes to the ovatio vrmodel 6250, dr model 6550 and crt-d model 6750. The device, as modified, will bemarketed under the trade name paradym vr model 8250 and paradym dr model 8550 withsmartview 2. 18ug1 and is indicated for use in patients who are at high risk of sudden cardiacdeath due to ventricular tachyarrhythmias and who have experienced one of the followingsituations: survival of at least one episode of cardiac arrest manifested by the loss ofconsciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustainedventricular tachycardia.
| Device | PARADYM CRT-D MODEL 8750 |
| 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 | 2009-09-24 |
| Decision Date | 2010-04-07 |
| PMA | P060027 |
| Supplement | S015 |
| Product Code | NIK |
| 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 |
| 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