PMA P220003S030
- Device
- PASCAL Precision Transcatheter Valve Repair System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S030
- Product code
- NKM
- Decision date
- 2026-06-18
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- adding a rework process for the tips of the PASCAL Precision Guide Sheath
Current openFDA PMA Record#
- Device
- PASCAL Precision Transcatheter Valve Repair System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S030
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-06-18
- Decision code
- OK30
- Date received
- 2026-05-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding a rework process for the tips of the PASCAL Precision Guide Sheath