PMA P220003S031
- Device
- PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S031
- Product code
- NKM
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- Mitral valve repair devices
- Approval order statement
- automation of a component cleaning process
Current openFDA PMA Record#
- Device
- PASCAL Precision implant system (20000IS and 20000ISM); PASCAL Precision guide sheath system (20000GS)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P220003
- Supplement
- S031
- Product code
- NKM
- Generic name
- Mitral valve repair devices
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of a component cleaning process