PMA P860057S220

Device: PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S220
Product code: DYE
Decision date: 2025-04-10
Classification: Cardiovascular
Generic name: replacement Heart-valve
Approval order statement: modifications to the Instructions for Use to reflect the 8-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis prospective cohort study

Current openFDA PMA Record#

Device: PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S220
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2025-04-10
Decision code: APPR
Date received: 2024-10-31
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: modifications to the Instructions for Use to reflect the 8-year findings of the Post-Approval Study (PAS) Report submitted for the long term follow-up of the PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis prospective cohort study