PMA P220003S032
- Device
- PASCAL Precision Transcatheter Valve Repair System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S032
- Product code
- NKM
- Decision date
- 2026-10-22
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- Approval for extending the device shelf-life to 3-years and to revise the shelf-life testing protocol
Current openFDA PMA Record#
- Device
- PASCAL Precision Transcatheter Valve Repair System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S032
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-10-22
- Decision code
- APPR
- Date received
- 2026-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the device shelf-life to 3-years and to revise the shelf-life testing protocol