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 | Perceval S Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP150011 Supplement NumberS023 Date Received03/03/2022 Decision Date03/07/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-03 |
| Decision Date | 2022-03-07 |
| PMA | P150011 |
| Supplement | S023 |
| 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 | CORCYM Canada Corp. 5005 North Fraser Way burnaby V5J 5 PMA NumberP150011 Supplement NumberS023 Date Received03/03/2022 Decision Date03/07/2022 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 use Of A New Temperature Indicator |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150011 | Original Filing | |
| S026 | 2022-10-24 | 30-day Notice |
| S025 | 2022-06-29 | 30-day Notice |
| S024 | ||
| S023 | 2022-03-03 | 30-day Notice |
| S022 | 2021-02-16 | 30-day Notice |
| S021 | ||
| S020 | 2020-03-16 | Real-time Process |
| S019 | 2020-03-02 | 30-day Notice |
| S018 | 2020-01-13 | 30-day Notice |
| S017 | 2019-10-17 | 30-day Notice |
| S016 | 2019-03-01 | 30-day Notice |
| S015 | 2019-01-22 | Special (immediate Track) |
| S014 | 2018-12-10 | Special (immediate Track) |
| S013 | ||
| S012 | 2018-02-07 | 30-day Notice |
| S011 | 2017-07-24 | 135 Review Track For 30-day Notice |
| S010 | 2017-06-26 | 30-day Notice |
| S009 | 2017-02-16 | 30-day Notice |
| S008 | 2017-01-27 | 30-day Notice |
| S007 | 2017-01-19 | 30-day Notice |
| S006 | 2016-12-15 | Special (immediate Track) |
| S005 | 2016-08-11 | 135 Review Track For 30-day Notice |
| S004 | 2016-04-06 | 30-day Notice |
| S003 | 2016-03-31 | 30-day Notice |
| S002 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S001 | 2016-01-27 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 18022057015034 | P150011 | 000 |
| 08022057014979 | P150011 | 000 |
| 08022057014825 | P150011 | 000 |
| 08022057014795 | P150011 | 000 |
| 08022057014788 | P150011 | 000 |
| 08022057014771 | P150011 | 000 |
| 08022057014337 | P150011 | 000 |
| 08022057014252 | P150011 | 000 |
| 08022057014245 | P150011 | 000 |
| 08022057015563 | P150011 | 000 |
| 08022057015556 | P150011 | 000 |
| 08022057015549 | P150011 | 000 |
| 00896208000412 | P150011 | 000 |
| 00896208000429 | P150011 | 000 |
| 00896208000436 | P150011 | 000 |
| 08022057014849 | P150011 | 000 |
| 08022057014832 | P150011 | 000 |
| 08022057014887 | P150011 | 000 |
| 08022057014870 | P150011 | 000 |
| 08022057014863 | P150011 | 000 |
| 08022057014856 | P150011 | 000 |
| 00896208000443 | P150011 | 000 |
| 08022057015532 | P150011 | 000 |
| 00896208000825 | P150011 | 013 |
| 00896208000818 | P150011 | 013 |
| 00896208000801 | P150011 | 013 |
| 00896208000795 | P150011 | 013 |