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 | Solo Smart Heart Valve |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | CORCYM Canada Corp.5005 North Fraser Wayburnaby V5J 5 PMA NumberP130011 Supplement NumberS011 Date Received06/29/2022 Decision Date07/28/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-07-28 |
| PMA | P130011 |
| Supplement | S011 |
| 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 NumberP130011 Supplement NumberS011 Date Received06/29/2022 Decision Date07/28/2022 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 Decrease In The Number Of Samples Used In The Limulus Amoebocyte Lysate Testing Performed Per Sterilization Batch |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130011 | Original Filing | |
| S011 | 2022-06-29 | 30-day Notice |
| S010 | 2022-03-03 | 30-day Notice |
| S009 | 2020-03-02 | 30-day Notice |
| S008 | 2020-01-13 | 30-day Notice |
| S007 | 2019-03-01 | 30-day Notice |
| S006 | 2018-02-07 | 30-day Notice |
| S005 | 2016-08-11 | 135 Review Track For 30-day Notice |
| S004 | 2016-03-31 | 30-day Notice |
| S003 | 2016-01-27 | 135 Review Track For 30-day Notice |
| S002 | 2015-12-07 | 135 Review Track For 30-day Notice |
| S001 | 2015-06-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00896208000498 | P130011 | 000 |
| 00896208000481 | P130011 | 000 |
| 00896208000474 | P130011 | 000 |
| 00896208000467 | P130011 | 000 |
| 00896208000405 | P130011 | 000 |
| 00896208000399 | P130011 | 000 |
| 00896208000382 | P130011 | 000 |
| 00896208000375 | P130011 | 000 |