PMA P150048S101
- Device
- INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S101
- Product code
- LWR
- Decision date
- 2026-06-03
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- the addition of a new cleanroom to an existing manufacturing facility
Current openFDA PMA Record#
- Device
- INSPIRIS RESILIA Aortic Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150048
- Supplement
- S101
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new cleanroom to an existing manufacturing facility