PMA P150036S078
- Device
- EDWARDS INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S078
- Product code
- LWR
- Decision date
- 2025-10-16
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom
Current openFDA PMA Record#
- Device
- EDWARDS INTUITY Elite Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S078
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2025-10-16
- Decision code
- OK30
- Date received
- 2025-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom