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 | Epic™, Epic™ Supra and Epic™ Plus Tissue Heart Valves, Biocor™ and Biocor™ Supra Tissue Heart Valves |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP040021 Supplement NumberS049 Date Received03/16/2022 Decision Date04/14/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-04-14 |
| PMA | P040021 |
| 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 NumberP040021 Supplement NumberS049 Date Received03/16/2022 Decision Date04/14/2022 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 the Addition Of Three New Tissue Suppliers/abbatoirs |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040021 | Original Filing | |
| S051 | 2022-11-18 | 30-day Notice |
| S050 | 2022-04-06 | 30-day Notice |
| S049 | 2022-03-16 | 30-day Notice |
| S048 | 2021-11-08 | 30-day Notice |
| S047 | 2021-06-21 | Real-time Process |
| S046 | 2021-04-30 | Special (immediate Track) |
| S045 | 2020-11-24 | 30-day Notice |
| S044 | 2020-09-15 | 30-day Notice |
| S043 | 2020-03-27 | 30-day Notice |
| S042 | 2019-11-13 | 30-day Notice |
| S041 | 2019-05-09 | 30-day Notice |
| S040 | 2019-02-27 | 30-day Notice |
| S039 | 2019-02-13 | 30-day Notice |
| S038 | 2019-01-24 | 30-day Notice |
| S037 | 2018-10-24 | Real-time Process |
| S036 | 2018-05-14 | 30-day Notice |
| S035 | 2018-03-27 | 30-day Notice |
| S034 | 2018-01-11 | 30-day Notice |
| S033 | 2017-11-28 | 30-day Notice |
| S032 | 2017-09-06 | 30-day Notice |
| S031 | ||
| S030 | 2016-12-22 | 30-day Notice |
| S029 | 2016-07-01 | 30-day Notice |
| S028 | 2016-03-29 | Normal 180 Day Track No User Fee |
| S027 | 2015-12-30 | 135 Review Track For 30-day Notice |
| S026 | 2015-01-21 | 30-day Notice |
| S025 | 2014-02-28 | 30-day Notice |
| S024 | 2013-06-10 | 135 Review Track For 30-day Notice |
| S023 | 2013-03-05 | Real-time Process |
| S022 | 2012-04-17 | Normal 180 Day Track No User Fee |
| S021 | 2012-03-22 | Special (immediate Track) |
| S020 | 2011-08-17 | Real-time Process |
| S019 | 2011-07-28 | 135 Review Track For 30-day Notice |
| S018 | 2011-06-06 | 135 Review Track For 30-day Notice |
| S017 | ||
| S016 | 2011-01-06 | Normal 180 Day Track No User Fee |
| S015 | 2010-10-18 | Normal 180 Day Track No User Fee |
| S014 | 2010-09-30 | Normal 180 Day Track No User Fee |
| S013 | 2010-09-30 | 30-day Notice |
| S012 | 2010-06-23 | 135 Review Track For 30-day Notice |
| S011 | 2009-08-17 | Normal 180 Day Track No User Fee |
| S010 | 2009-08-14 | 30-day Notice |
| S009 | 2009-05-27 | 30-day Notice |
| S008 | 2009-03-27 | Normal 180 Day Track No User Fee |
| S007 | 2008-07-31 | Normal 180 Day Track |
| S006 | 2008-03-12 | Normal 180 Day Track No User Fee |
| S005 | 2006-09-20 | Normal 180 Day Track No User Fee |
| S004 | 2006-09-29 | Panel Track |
| S003 | 2006-08-07 | Normal 180 Day Track |
| S002 | ||
| S001 | 2005-09-06 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734055376 | P040021 | 003 |
| 05414734055505 | P040021 | 003 |
| 05414734055499 | P040021 | 003 |
| 05414734055482 | P040021 | 003 |
| 05414734055475 | P040021 | 003 |
| 05414734055468 | P040021 | 003 |
| 05414734055451 | P040021 | 003 |
| 05414734055444 | P040021 | 003 |
| 05414734055437 | P040021 | 003 |
| 05414734055420 | P040021 | 003 |
| 05414734055413 | P040021 | 003 |
| 05414734055406 | P040021 | 003 |
| 05414734055390 | P040021 | 003 |
| 05414734055383 | P040021 | 003 |
| 05414734055512 | P040021 | 003 |
| 05414734055529 | P040021 | 004 |
| 05414734055659 | P040021 | 004 |
| 05414734055642 | P040021 | 004 |
| 05414734055635 | P040021 | 004 |
| 05414734055628 | P040021 | 004 |
| 05414734055611 | P040021 | 004 |
| 05414734055604 | P040021 | 004 |
| 05414734055598 | P040021 | 004 |
| 05414734055581 | P040021 | 004 |
| 05414734055574 | P040021 | 004 |
| 05414734055567 | P040021 | 004 |
| 05414734055550 | P040021 | 004 |
| 05414734055543 | P040021 | 004 |
| 05414734055536 | P040021 | 004 |
| 05414734055666 | P040021 | 004 |