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 | SynCardia temporary Total Artificial Heart (TAH-t) System |
| Generic Name | Artificial Heart |
| Applicant | SYNCARDIA SYSTEMS, LLC1992 E. Silverlake Rd.tucson, AZ 85713 PMA NumberP030011 Supplement NumberS082 Date Received08/23/2022 Decision Date09/22/2022 Product Code LOZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-09-22 |
| PMA | P030011 |
| Supplement | S082 |
| Product Code | LOZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SYNCARDIA SYSTEMS, LLC 1992 E. Silverlake Rd. tucson, AZ 85713 PMA NumberP030011 Supplement NumberS082 Date Received08/23/2022 Decision Date09/22/2022 Product Code LOZ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add New Sub-supplier For Freedom Onboard Battery PCBA And To Add New Sub-components To Freedom Onboard Battery PCBA. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00858000003008 | P030011 | 002 |
| 00858000003114 | P030011 | 011 |
| 00858000003107 | P030011 | 011 |
| 00858000003077 | P030011 | 011 |
| 00858000003121 | P030011 | 020 |
| 00858000003084 | P030011 | 020 |