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 | Trifecta |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP100029 Supplement NumberS049 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-18 |
| Decision Date | 2022-12-14 |
| PMA | P100029 |
| Supplement | S049 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 177 County Road B. East st. Paul, MN 55117 PMA NumberP100029 Supplement NumberS049 Date Received11/18/2022 Decision Date12/14/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modification To The Test Method Used To Verify Sterilant, Storage, And Fixation Solution Concentrations |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100029 | Original Filing | |
| S049 | 2022-11-18 | 30-day Notice |
| S048 | 2022-10-20 | 30-day Notice |
| S047 | 2022-10-20 | 30-day Notice |
| S046 | 2022-03-16 | 30-day Notice |
| S045 | 2021-11-08 | 30-day Notice |
| S044 | ||
| S043 | 2020-09-15 | 30-day Notice |
| S042 | 2019-11-13 | 30-day Notice |
| S041 | ||
| S040 | 2019-05-09 | 30-day Notice |
| S039 | 2019-02-27 | 30-day Notice |
| S038 | 2019-02-13 | 30-day Notice |
| S037 | 2018-10-23 | 30-day Notice |
| S036 | 2018-09-12 | 30-day Notice |
| S035 | 2018-08-13 | Special (immediate Track) |
| S034 | 2018-05-14 | 30-day Notice |
| S033 | 2018-03-27 | 30-day Notice |
| S032 | 2018-03-22 | 30-day Notice |
| S031 | 2018-02-15 | 30-day Notice |
| S030 | 2018-02-01 | 30-day Notice |
| S029 | 2018-01-11 | 30-day Notice |
| S028 | 2017-11-28 | 30-day Notice |
| S027 | 2017-10-27 | 30-day Notice |
| S026 | ||
| S025 | 2017-03-07 | 30-day Notice |
| S024 | 2016-12-22 | 30-day Notice |
| S023 | 2016-12-09 | 30-day Notice |
| S022 | 2016-07-01 | 30-day Notice |
| S021 | 2015-10-02 | Normal 180 Day Track |
| S020 | 2015-08-28 | 30-day Notice |
| S019 | 2015-01-21 | 30-day Notice |
| S018 | 2014-11-13 | 30-day Notice |
| S017 | 2014-09-05 | 30-day Notice |
| S016 | 2013-06-10 | 135 Review Track For 30-day Notice |
| S015 | 2013-05-28 | 135 Review Track For 30-day Notice |
| S014 | 2012-07-19 | Special (immediate Track) |
| S013 | 2012-04-05 | Real-time Process |
| S012 | 2012-03-27 | 30-day Notice |
| S011 | 2012-03-22 | Special (immediate Track) |
| S010 | 2012-01-23 | 30-day Notice |
| S009 | 2011-09-27 | 30-day Notice |
| S008 | 2011-08-17 | Real-time Process |
| S007 | 2011-08-08 | 30-day Notice |
| S006 | 2011-06-09 | 30-day Notice |
| S005 | 2011-06-06 | 30-day Notice |
| S004 | 2011-06-06 | 135 Review Track For 30-day Notice |
| S003 | 2011-05-20 | Normal 180 Day Track No User Fee |
| S002 | 2011-04-27 | 135 Review Track For 30-day Notice |
| S001 | 2011-04-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734052016 | P100029 | 000 |
| 05414734052023 | P100029 | 000 |
| 05414734052030 | P100029 | 000 |
| 05414734052047 | P100029 | 000 |
| 05414734052054 | P100029 | 000 |
| 05414734052061 | P100029 | 000 |
| 05415067018205 | P100029 | 021 |
| 05415067018212 | P100029 | 021 |
| 05415067018229 | P100029 | 021 |
| 05415067018236 | P100029 | 021 |
| 05415067018243 | P100029 | 021 |
| 05415067018250 | P100029 | 021 |