PMA P150048S029
- Device
- KONECT RESILIA Aortic Valved Conduit AVC
- Applicant
- Edwards Lifesciences, LLC
- Product code
- LWR
- Decision date
- 2020-07-10
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Approval for the KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A.
Current openFDA PMA Record#
- Device
- KONECT RESILIA Aortic Valved Conduit AVC
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S029
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-07-10
- Decision code
- APPR
- Date received
- 2018-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the KONECT RESILIA Aortic Valved Conduit (AVC), Model 11060A.