PMA P150048S069
- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON
- Applicant
- EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS069 Date Received10/12/2022 Decision Date10/19/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- PMA number
- P150048
- Supplement
- S069
- Product code
- LWR
- Decision date
- 2022-10-19
- Generic name
- Heart-valve, Non-allograft Tissue
Current openFDA PMA Record
- Device
- Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S069
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2022-10-19
- Decision code
- OK30
- Date received
- 2022-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in yarn extruder and an additional bias cloth manufacturing step.