PMA P220003S028
- Device
- PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S028
- Product code
- NKM
- Decision date
- 2026-09-23
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for the PASCAL Ace with Capture Clarity Valve Repair System.
Current openFDA PMA Record#
- Device
- PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S028
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-09-23
- Decision code
- APPR
- Date received
- 2026-03-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the PASCAL Ace with Capture Clarity Valve Repair System.