PMA P150048S064
- Device
- Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S064
- Product code
- LWR
- Decision date
- 2022-04-26
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Modifications to the stent assembly process.
Current openFDA PMA Record#
- Device
- Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S064
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-04-26
- Decision code
- OK30
- Date received
- 2022-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the stent assembly process.