PMA P150048S025
- Device
- Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S025
- Product code
- LWR
- Decision date
- 2018-08-15
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval to implement a in-process inspection for damage to glass chemical containers.
Current openFDA PMA Record#
- Device
- Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S025
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-08-15
- Decision code
- APPR
- Date received
- 2018-07-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement a in-process inspection for damage to glass chemical containers.