This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741; |
| 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 | 2018-12-20 |
| Decision Date | 2019-03-19 |
| PMA | P060027 |
| Supplement | S098 |
| Product Code | NIK |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 08031527012278 | P060027 | 032 |
| 08031527012810 | P060027 | 066 |
| 08031527015538 | P060027 | 079 |
| 08031527015484 | P060027 | 079 |
| 08031527015569 | P060027 | 088 |