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PMA P150048S048

Device
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
Applicant
Edwards Lifesciences, LLC
PMA number
P150048
Supplement
S048
Product code
LWR
Decision date
2020-09-07
Generic name
heart-valve, non-allograft tissue
Approval order statement
IImplementation of a new washer/dryer to automate the process for cleaning and sanitizing fixtures and accessories used in Edwards Integrity Preservation Technology processing at the Irvine Facility.

Current openFDA PMA Record#

Device
Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
Applicant
Edwards Lifesciences, LLC
PMA number
P150048
Supplement
S048
Product code
LWR
Generic name
heart-valve, non-allograft tissue
Decision date
2020-09-07
Decision code
OK30
Date received
2020-08-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IImplementation of a new washer/dryer to automate the process for cleaning and sanitizing fixtures and accessories used in Edwards Integrity Preservation Technology processing at the Irvine Facility.