PMA P150048S059
- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S059
- Product code
- LWR
- Decision date
- 2021-11-18
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Addition of new cleanroom.
Current openFDA PMA Record#
- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S059
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-11-18
- Decision code
- OK30
- Date received
- 2021-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of new cleanroom.