PMA P150048S035
- Device
- Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S035
- Product code
- LWR
- Decision date
- 2019-06-12
- Classification
- Heart-valve, Non-allograft Tissue
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- Removal of APFO from the PTFE yarn resin.
Current openFDA PMA Record#
- Device
- Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S035
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2019-06-12
- Decision code
- OK30
- Date received
- 2019-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of APFO from the PTFE yarn resin.