Approval for several design changes to the syncardia companion 2driver pressure sensor printed circuit board assembly (pcba) and the addition of an alternate supplier for the pressure sensor pcba.
| Device | SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART |
| Classification Name | Artificial Heart |
| Generic Name | Artificial Heart |
| Applicant | SYNCARDIA SYSTEMS, LLC |
| Date Received | 2014-08-04 |
| Decision Date | 2014-09-12 |
| PMA | P030011 |
| Supplement | S027 |
| Product Code | LOZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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