- Device
- Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S041
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-11-24
- Decision code
- OK30
- Date received
- 2019-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility