PMA P150048S032

Device: Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S032
Product code: LWR
Decision date: 2019-04-04
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Implementation of manufacturing changes to the Model 11500A, Model 11000A, and Model 11000M products.

Current openFDA PMA Record#

Device: Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S032
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2019-04-04
Decision code: OK30
Date received: 2019-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of manufacturing changes to the Model 11500A, Model 11000A, and Model 11000M products.