FDA.reportPublic FDA data

PMA P150048S044

Device
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V
Applicant
Edwards Lifesciences, LLC
PMA number
P150048
Supplement
S044
Product code
LWR
Decision date
2020-03-05
Generic name
heart-valve, non-allograft tissue
Approval order statement
Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.

Current openFDA PMA Record#

Device
Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V
Applicant
Edwards Lifesciences, LLC
PMA number
P150048
Supplement
S044
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2020-03-05
Decision code
OK30
Date received
2020-02-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.