PMA P150048S023
- Device
- Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S023
- Product code
- LWR
- Decision date
- 2018-12-28
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for a change to the manufacturing sequence and removal of an inspection.
Current openFDA PMA Record#
- Device
- Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S023
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2018-12-28
- Decision code
- APPR
- Date received
- 2018-06-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the manufacturing sequence and removal of an inspection.