PMA P150048S052
- Device
- KONECT RESILIA Aortic Valved Conduit (AVC)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S052
- Product code
- LWR
- Decision date
- 2021-03-23
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Transfer of KONECT AVC final assembly from one building to another building within the Irvine, CA facility.
Current openFDA PMA Record#
- Device
- KONECT RESILIA Aortic Valved Conduit (AVC)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S052
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2021-03-23
- Decision code
- OK30
- Date received
- 2021-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of KONECT AVC final assembly from one building to another building within the Irvine, CA facility.