PMA P220003S026

Device: PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S026
Product code: NKM
Decision date: 2025-10-02
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: the addition of a new Ethylene Oxide (EO) Sterilization Line at the existing and approved EO sterilization facility

Current openFDA PMA Record#

Device: PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S026
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2025-10-02
Decision code: OK30
Date received: 2025-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new Ethylene Oxide (EO) Sterilization Line at the existing and approved EO sterilization facility