PMA P150048S054
- Device
- KONECT RESILIA Aortic Valved Conduit (AVC)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S054
- Product code
- LWR
- Decision date
- 2021-06-02
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Manufacturing process transfer of the Graft to Sewing Ring Sub-Assembly to a different cleanroom within the Irvine, CA facility.
Current openFDA PMA Record#
- Device
- KONECT RESILIA Aortic Valved Conduit (AVC)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S054
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-06-02
- Decision code
- OK30
- Date received
- 2021-05-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process transfer of the Graft to Sewing Ring Sub-Assembly to a different cleanroom within the Irvine, CA facility.