- Device
- EDWARDS INTUITY Elite Valve System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P150036
- Supplement
- S050
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2020-03-11
- Decision code
- OK30
- Date received
- 2020-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Eliminate the specification of "elastic" characteristic in pericardial tissue for tissue leaflets and the related visual inspection in the valve manufacturing process.