- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S062
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-11-16
- Decision code
- APPR
- Date received
- 2022-03-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate supplier of a component of the solution used for in-process bioburden reduction.