PMA P150048S042
- Device
- Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S042
- Product code
- LWR
- Decision date
- 2019-11-26
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Implementation of a new cleanroom for receiving inspection processes.
Current openFDA PMA Record#
- Device
- Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S042
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-11-26
- Decision code
- OK30
- Date received
- 2019-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new cleanroom for receiving inspection processes.