- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S049
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-10-28
- Decision code
- OK30
- Date received
- 2020-10-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a sampling plan in place of 100% dimensional inspection of the INSPIRIS wireform cover cloth.