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 | PASCAL Precision Transcatheter Valve Repair System |
| Generic Name | Mitral Valve Repair Devices |
| Applicant | Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-18 |
| Decision Date | 2022-11-20 |
| PMA | P220003 |
| Supplement | S002 |
| Product Code | NKM |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Edwards LifeSciences LLC one Edwards Way irvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM 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 Implement A Custom Automated Vision System For Part Detection On The Packaging Card During The Pouch Packaging And Inspection Process For The PASCAL Precision Implant Systems |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P220003 | Original Filing | |
| S005 | 2022-12-19 | 30-day Notice |
| S004 | 2022-11-15 | 30-day Notice |
| S003 | 2022-11-07 | 30-day Notice |
| S002 | 2022-10-18 | 30-day Notice |
| S001 | 2022-10-12 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00690103216981 | P220003 | 000 |
| 00690103216974 | P220003 | 000 |
| 00690103216967 | P220003 | 000 |
| 00690103216950 | P220003 | 000 |
| 00690103216943 | P220003 | 000 |