Approval for the trade name change of the subject device. The device will be marketed under the trade name syncardia temporary total artificial heart and is indicated for use in transplant-eligible candidates in imminent danger of death from irreversible biventricular failure.
| Device | SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART |
| Classification Name | Artificial Heart |
| Generic Name | Artificial Heart |
| Applicant | SYNCARDIA SYSTEMS, LLC |
| Date Received | 2010-01-15 |
| Decision Date | 2010-04-28 |
| PMA | P030011 |
| Supplement | S007 |
| Product Code | LOZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SYNCARDIA SYSTEMS, LLC 1992 E. Silverlake Rd. tucson, AZ 85713 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030011 | | Original Filing |
| S082 |
2022-08-23 |
30-day Notice |
| S081 | | |
| S080 | | |
| S079 |
2020-09-30 |
30-day Notice |
| S078 |
2020-02-12 |
30-day Notice |
| S077 | | |
| S076 |
2019-12-23 |
30-day Notice |
| S075 | | |
| S074 |
2019-10-28 |
Special (immediate Track) |
| S073 |
2019-07-16 |
Special (immediate Track) |
| S072 | | |
| S071 |
2019-06-18 |
30-day Notice |
| S070 | | |
| S069 |
2019-05-28 |
30-day Notice |
| S068 |
2019-03-06 |
Real-time Process |
| S067 |
2019-01-22 |
30-day Notice |
| S066 |
2018-12-10 |
30-day Notice |
| S065 |
2018-11-19 |
30-day Notice |
| S064 | | |
| S063 | | |
| S062 |
2018-06-14 |
30-day Notice |
| S061 |
2018-03-30 |
30-day Notice |
| S060 |
2018-02-16 |
30-day Notice |
| S059 |
2017-11-14 |
30-day Notice |
| S058 |
2017-11-01 |
30-day Notice |
| S057 |
2017-11-01 |
Special (immediate Track) |
| S056 |
2017-09-01 |
30-day Notice |
| S055 |
2017-05-08 |
Real-time Process |
| S054 |
2017-04-07 |
135 Review Track For 30-day Notice |
| S053 | | |
| S052 |
2017-03-16 |
30-day Notice |
| S051 |
2017-03-13 |
135 Review Track For 30-day Notice |
| S050 |
2017-03-03 |
135 Review Track For 30-day Notice |
| S049 |
2017-03-02 |
Special (immediate Track) |
| S048 |
2017-02-24 |
Real-time Process |
| S047 |
2017-02-07 |
30-day Notice |
| S046 |
2016-09-07 |
Real-time Process |
| S045 |
2016-08-22 |
30-day Notice |
| S044 |
2016-05-13 |
Real-time Process |
| S043 |
2016-03-30 |
Special (immediate Track) |
| S042 |
2016-02-22 |
30-day Notice |
| S041 |
2016-02-22 |
30-day Notice |
| S040 |
2016-02-22 |
30-day Notice |
| S039 |
2016-01-21 |
Real-time Process |
| S038 |
2015-12-31 |
135 Review Track For 30-day Notice |
| S037 |
2015-12-11 |
30-day Notice |
| S036 |
2015-10-19 |
Special (immediate Track) |
| S035 |
2015-09-29 |
30-day Notice |
| S034 |
2015-08-05 |
Real-time Process |
| S033 |
2015-08-03 |
Real-time Process |
| S032 |
2015-07-31 |
Normal 180 Day Track No User Fee |
| S031 |
2015-06-29 |
30-day Notice |
| S030 |
2014-11-20 |
Real-time Process |
| S029 |
2014-09-03 |
30-day Notice |
| S028 | | |
| S027 |
2014-08-04 |
Real-time Process |
| S026 |
2014-07-10 |
30-day Notice |
| S025 |
2014-04-18 |
Normal 180 Day Track No User Fee |
| S024 |
2014-04-03 |
Normal 180 Day Track |
| S023 |
2013-12-18 |
Real-time Process |
| S022 |
2013-11-13 |
30-day Notice |
| S021 |
2013-08-07 |
Normal 180 Day Track No User Fee |
| S020 |
2013-02-15 |
Normal 180 Day Track |
| S019 |
2013-02-11 |
135 Review Track For 30-day Notice |
| S018 | | |
| S017 | | |
| S016 |
2012-06-21 |
Normal 180 Day Track No User Fee |
| S015 |
2012-06-08 |
Real-time Process |
| S014 | | |
| S013 |
2012-06-01 |
Real-time Process |
| S012 |
2012-04-09 |
135 Review Track For 30-day Notice |
| S011 |
2011-06-10 |
Normal 180 Day Track |
| S010 |
2011-01-25 |
30-day Notice |
| S009 |
2010-11-22 |
Normal 180 Day Track No User Fee |
| S008 |
2010-06-21 |
Normal 180 Day Track No User Fee |
| S007 |
2010-01-15 |
Normal 180 Day Track No User Fee |
| S006 |
2009-11-23 |
30-day Notice |
| S005 | | |
| S004 | | |
| S003 |
2008-06-10 |
Normal 180 Day Track No User Fee |
| S002 |
2007-04-26 |
30-day Notice |
| S001 |
2005-05-10 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices