Approval for the smartview home monitor. The device, as modified, will be marketed under the trade name smartview home monitor and is indicated for use with sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; it will not operate with other lines such as and not limited to digital, dsl or optical for the pstn device and the smartview monitor is designed for use with the sorin radio frequency implanted cardiac device only for gprs devices.
| Device | PARADYM RF CRT-D |
| 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 | 2012-03-13 |
| Decision Date | 2013-05-09 |
| PMA | P060027 |
| Supplement | S038 |
| 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