Approval for:1) a firmware patch for the implantable device with the microprocessor (up) v4b; 2) a new firmware version for the up v4c and v4d; 3) the hardware modifications for the implantable devices; 4) the updates/ modifications for the programmer application software; and 5) the updates/ modifications for the remote monitoring system (rms).
| Device | PARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 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 | 2013-08-21 |
| Decision Date | 2014-03-06 |
| PMA | P060027 |
| Supplement | S053 |
| 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