- Device
- PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S001
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2022-10-19
- Decision code
- OK30
- Date received
- 2022-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in yarn extruder and an additional bias cloth manufacturing step.